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Intrathecal Drug Delivery Patient Information for Medtronic Infusion Systems This booklet was written to help you understand Medtronic Intrathecal Drug Delivery Systems and the devices that control them. This guide contains important information about the devices. We encourage you to read it carefully and share it with your family members or caregivers. We understand that you may have many questions. Medtronic Neurological Patient Services is here to help, a resource that is free to you. Patient Services has a lot to offer. They can: • Register your implanted system (with information provided by your doctor). The registration is used to track your implanted device in compliance with FDA requirements. We can assure you that Medtronic does not sell or release your device registration to other companies. For information on the Medtronic privacy policy, visit: www.medtronic.com/statements/privacy.html. • Provide you with a permanent identification card. This card should be kept with you at all times so that information about your system is available in case of an emergency. The card is sent to you after your doctor registers your system. • The identification card is a multilingual airport/security card that says (in seven languages) you have an implanted medical device (English, French, German, Spanish, Italian, Chinese, and Japanese). • Answer questions you may have about traveling. • Keep your information current to better serve you and your doctor. If you move or change doctors please notify Patient Services as soon as possible. Medtronic Patient Services is available to take your calls Monday through Friday from 8 a.m. to 5 p.m. Central Standard Time at our toll-free number: 1-800-510-6735 or if you are outside the U.S. call 763-505-5000. Best results are achieved when you are fully informed about the therapy risks and benefits, surgical procedure, follow-up requirements, and self-care responsibilities. Maximum benefits from the infusion system require long-term post-surgical management. If you are receiving intrathecal drug delivery for pain management, you may be interested in our Living Well newsletter. Living Well is a periodic email newsletter designed for people who are using a Medtronic implantable device to treat chronic pain. To register for the newsletter visit our Web site at: www.medtroniclivingwell.com. If you are using the SynchroMed System for the treatment of severe spasticity, the patient newsletter called Connecting may be of interest to you. You can register for this newsletter at [email protected] or call 1-800-510-6735, ext. 86735. Table of Contents How to Use This Booklet ............................................................................ 3 SynchroMed® Infusion System ................................................................ 4 Overview......................................................................................................4 Purpose of the SynchroMed System (Indications).......................4 How the SynchroMed System Works ............................................... 5 Components & Dimensions ................................................................. 6 Product Attributes ................................................................................... 7 IsoMed® Constant-Flow Infusion System ............................................. 8 Overview...................................................................................................... 8 Purpose of the IsoMed System (Indications) ................................. 8 How the IsoMed Pump Works ............................................................. 8 IsoMed Components & Dimensions .................................................. 9 Product Attributes ................................................................................. 10 Implant Procedure .......................................................................................10 Overview.................................................................................................... 10 FAQs ............................................................................................................. 11 Post-Surgery Care .......................................................................................12 Overview.................................................................................................... 12 FAQs .............................................................................................................13 Electromagnetic Interference (EMI) & How it May Affect the Pump ..............................................................15 Overview.....................................................................................................15 High-Magnetic-Field Devices ..................................................................16 General Warnings & Precautions/ Medical Procedures & Equipment ..........................................................17 Overview.....................................................................................................17 Other Important Information ..................................................................21 Activities/Common Questions About the Pump ............................22 FAQs ........................................................................................................... 22 Contraindications/Risks ............................................................................24 Surgical Risks ............................................................................................25 Device Risks ..............................................................................................25 1 Battery & Alarms ........................................................................................26 SynchroMed II Pump ............................................................................. 26 Synchromed EL Pump ...........................................................................27 IsoMed Pump ........................................................................................... 29 Precautions ...................................................................................................30 Glossary ..........................................................................................................31 Device Brief Summaries ............................................................................ 33 Refill Schedule .............................................................................................. 37 2 How to Use This Booklet Words that appear in bold type are defined in the glossary at the back of this booklet. This booklet is not meant to cover all aspects of the product, surgery, or therapy. Talk with your doctor before making any decisions about treatment options. Your doctor should tell you about: • The components of your infusion system and where they are located in your body. • Any instructions you need to know about using your infusion system. • The indications, contraindications, warnings, and precautions for the infusion system. • Your specific treatment. • Informing any health care personnel that you have an implanted infusion system before any procedure is begun. • Contacting your doctor if you notice any unusual symptoms or signs. • The importance of reading this booklet. 3 SynchroMed® Infusion System Overview The SynchroMed Infusion System (SynchroMed II system or SynchroMed EL system) offers a fully implantable and programmable method of continuous drug delivery. The SynchroMed EL system has been in use clinically since 1982 and commercially since 1988. The SynchroMed II system has been in commercial use since 2004. Programmability of the SynchroMed Infusion System allows: • Dosages to be varied throughout the day and tailored to match individual's medication needs. • The potential for lower doses (compared with oral drugs) which may result in reduced side effects. • Non-invasive dose changes. Purpose of the SynchroMed System (Indications) A SynchroMed Infusion System is indicated when patient therapy requires long-term infusion of drugs or fluids. Pump and catheter placement for intrathecal drug delivery 4 How the SynchroMed System Works • The pump has three sealed chambers. One contains an electronic module and battery; another contains a peristaltic pump (to move the contents along) and a drug reservoir; and a third contains an inert (stable) gas. • The medication enters the pump through the reservoir fill port and passes through a valve on the reservoir. An inert gas inside the pump puts pressure on the reservoir, forcing the medication through a bacteria-retentive filter and into a peristaltic pump. The action of the pump moves the medication from the pump through the catheter to the infusion site. • A microprocessor controls the rate at which the pump delivers medication. Your doctor may program the pump to deliver different amounts of medication at different times of the day, depending on individual needs. Internal components of the SynchroMed pump (SynchroMed EL pump is pictured here.) 5 SynchroMed Infusion System Components & Dimensions Catheter Access Port Reservoir fill port Catheter Access Port Reservoir fill port Components The SynchroMed Infusion System (either the SynchroMed II pump or the SynchroMed EL pump) consists of: • Implantable, programmable pump. Catheter • Implantable catheter. • External programmer used by healthcare providers. The pump is a round, titanium, battery-powered device that stores the medication and delivers prescribed amounts into your body. The pump includes a reservoir, reservoir fill port, and (in most cases) a catheter access port: • The reservoir is the chamber inside the pump where the medication is stored. • In the center of the pump is the reservoir fill port. In the middle of the port is a self-sealing silicone septum. A needle is inserted through the skin and through the septum to refill the pump. • The doctor uses the catheter access port (CAP) to deliver medications or sterile solutions directly into the catheter, without going through the pump. The doctor might also use the catheter access port for some diagnostic purposes, such as testing to make sure medication is able to flow through the length of the catheter. The catheter is a thin, flexible tube that connects to the pump. The pump delivers medication through the catheter to a specific site in your body where it can have the best effect. The doctor trims the catheter to the appropriate length for your body size. Implantable catheter used with SynchroMed pumps 6 The programmer is used by clinicians to interrogate and program the pump. The programmer uses telemetry to communicate with the pump. Through telemetry, programming instructions are sent to the pump and information is received from the pump. The doctor or nurse uses the clinician programmer to establish your prescription. N'Vision programmer Model 8840 for clinicians Dimensions SynchroMed (with CAP) Height Diameter (with CAP) SynchroMed II (20 ml) 19.5 mm (3/4") 87.5 mm (3.4") Weight empty/full 165/185 g (5.8 oz / 6.5 oz) SynchroMed II (40 ml) 26 mm (1") 87.5 mm (3.4") 175/215 g (6.2 oz / 7.6 oz) SynchroMed EL (10 ml) 21.6 mm (0.85") 85.2 mm (3.35") 185/195 g (6.5 oz /6.9 oz) SynchroMed EL (18 ml) 27.5 mm (1.08") 85.2 mm (3.35") 205/223 g (7.2 oz / 7.9 oz) Product Attributes • The programmability of the SynchroMed system enables your doctor to tailor your therapy and dosing to best meet your needs. • Programming technology allows dosing changes between refills to be made non-invasively. • Different reservoir sizes provide flexibility in meeting your preferences of size and refill schedules. • 20 ml and 40 ml for the SynchroMed II system • 10 ml and 18 ml for the SynchroMed EL system • The SynchroMed infusion system offers precise, accurate dosing. 7 IsoMed® Constant-Flow Infusion System Overview The IsoMed Constant-Flow Infusion System is a fully implantable drug infusion system. It has been used clinically since 1997 and was commercially released in the U.S. in 2000. The system offers: IsoMed® pump • Constant-flow infusion. • Accurate dosage delivery. • Thin design. Purpose of the IsoMed System (Indications) The IsoMed System is used to treat chronic intractable pain through continuous delivery of pain medication into the intrathecal space. The IsoMed system is not indicated for the treatment of spasticity. How the IsoMed Pump Works The pump contains two sealed chambers. One chamber contains the reservoir and capillary tubing. The length of the capillary tubing determines the amount of medication the pump dispenses each day. The longer the capillary tubing, the smaller the daily volume of medication delivered. The second sealed chamber contains a gas that provides the pressure that forces the medication through the pump. Medication is injected into the expandable reservoir through the reservoir fill port. The gas in the sealed chamber puts pressure on the reservoir. The pressure forces the medication through a bacteria-retentive filter and into the capillary tubing and implanted catheter. Internal components of the IsoMed pump 8 Catheter access port Components & Dimensions Components catheter Reservoir fill port The IsoMed System consists of: • Implantable pump. • Implantable catheter. The IsoMed pump stores and dispenses drugs at a constant flow rate set during the manufacturing process. The flow rate and drug concentration determine the drug dose. The pump is a round, titanium, device that stores the medication and delivers set amounts into your body. The pump includes a reservoir, reservoir fill port, and catheter access port: • The reservoir is the chamber inside the pump where the medication is stored. • In the center of the pump is the reservoir fill port. In the middle of the port is a self-sealing silicone septum. A needle is inserted through the skin and through the septum to refill the pump. • The doctor uses the catheter access port (CAP) to deliver medications or sterile solutions directly into the catheter, without going through the pump. The doctor might also use the catheter access port for some diagnostic purposes, such as testing to make sure medication is able to flow through the length of the catheter. The catheter is a thin, flexible tube that connects to the pump. The pump delivers medication through the catheter to a specific site in your body where it can have the best effect. The doctor trims the catheter to the appropriate length for your body size. 9 Dimensions All Dimensions are approximate IsoMed Thickness (including septum) Diameter Weight (empty) IsoMed (20 ml) 24 mm (0.95") 77 mm (3") 113 g (4.0 oz) IsoMed (35 ml) 29 mm (1.1") 77 mm (3") 116 g (4.1 oz) IsoMed (60 ml) 37 mm (approx. 1.5") 77 mm (3") 120 g (4.2 oz) Product Attributes • Constant drug flow rates meet the needs of people who require a constant amount of medication throughout the day. • The pump requires no programming. • A choice of three reservoir sizes (20 ml, 35 ml, or 60 ml) provides flexibility in meeting your preferences of size and refill schedules. • The low-profile design meets the needs of a wide range of body types. • The IsoMed system offers precise, accurate dosing. • Long implant life may mean fewer pump replacement surgeries. Implant Procedure (for all pumps) Overview The pump is implanted during a surgical procedure that may require a brief hospital stay. Before the surgery, you and your doctor will decide where to position the pump for your comfort. During the surgical procedure, the doctor will form a pocket under the skin that is large enough to hold the pump. This incision is usually in the abdominal area. A second incision is made on the back where one end of the catheter will be placed in the intrathecal space. The other end of the catheter is tunneled under the skin and attached to the pump. Once the pump and catheter are in place, the incisions are closed and the surgery is complete. 10 FAQs Q: What type of anesthesia is used? A: Typically, the implant is performed under general anesthesia. However, you may want to talk with your doctor about other options. Q: Can a previous abdominal incision be used to implant the pump? A: Usually not. The incision needs to be made where the pump will be implanted to help properly anchor the pump. Proper anchoring helps keep the pump in place. This may help minimize your discomfort and speed recovery. Q: How big are the incisions? A: The abdominal incision is about 6 inches long. This is where the pump is placed. A second incision (about 2–3 inches long) is made on your back. This incision is used to place one end of the catheter into the intrathecal space. The other end of the catheter is tunneled under the skin and connected to the pump. Q: On average, how long does the surgery take? A: Times vary depending on individual doctor technique. On average, the procedure takes about 1 to 2 hours from start to finish. Talk with your doctor about the specifics and duration of the procedure. Q: What is the average length of the hospital stay? A: Depending on the doctor’s preference and hospital policy, a brief hospital stay may be recommended. However, the procedure may be performed on an outpatient basis, which means no overnight stay is required. Q: Between which vertebrae is the catheter placed? A: That depends on your specific condition(s) and the results you received from the trial. Your doctor will advise you of the recommended catheter location. Q: Is spinal cord damage possible? A: In rare cases, spinal cord damage may occur from surgical placement of the catheter. 11 Q: Are there other side effects associated with placing the catheter in the intrathecal space? A: In some cases, you may experience a spinal headache as a result of a needle or catheter being placed in the intrathecal space. A spinal headache is caused when cerebrospinal fluid (the fluid that surrounds the spinal cord) leaks out of the intrathecal space. This headache may correct itself, or the doctor may treat it. Other potential side effects are listed in the Adverse Events section of the brief summary (page 37). For surgical risks, please refer to page 25. Post-Surgery Care Overview After surgery, there will be some discomfort and tenderness where the pump and catheter are implanted. Your doctor may prescribe medication to relieve the pain caused by the surgery and antibiotics to prevent infection. If you notice any swelling, pain, or redness near the incisions, notify your doctor or nurse. After the implant, the doctor may recommend that you restrict activity for six to eight weeks. Once the incisions have healed, the pump site and the catheter site require no special care. However, you should talk with your doctor before you perform any excessive or repetitive activities that may damage the pump or catheter. 12 FAQs Q: Will my pump be filled with medication immediately following the implant procedure? A: Depending on the doctor’s preference, the pump may be filled during or after surgery. However, some doctors recommend a short waiting period to allow you to recover from surgery and get adjusted to the pump. Q: How long will it take before I start receiving benefit from my pump? A: You will begin receiving therapy as soon as the pump is filled with medication and the medication is delivered through the catheter to the intrathecal space. However, depending on the medication, it may take several weeks before you begin to experience benefits from the medication. During this transition period, the doctor may reduce or eliminate your other medication(s). Q: What if I have no improvement after the pump is implanted? A: Let your doctor know if you are not receiving adequate control of your condition and/or symptoms. If you have a SynchroMed pump, the doctor can reprogram the pump to adjust the amount of medication it delivers. If you have an IsoMed pump, the doctor may need to use a syringe to remove the medication from the pump and refill the pump with a different drug concentration. Q: How often will my pump need to be refilled and what happens if I miss a refill appointment? A: The frequency with which you'll need your pump refilled will depend on the type of drug used in your pump, and the amount of medication you are receiving. Your doctor will tell you how often you'll need to have your pump filled. It is critical that you return to your clinic for refills at the prescribed times. Failure to return to the clinic for refills at the prescribed times could result in the actual flow rate of the pump being less than expected, resulting in a loss of or change in therapy that could lead to serious injury or death. Failure to return at the prescribed times could also damage the pump and require surgery to replace the pump. 13 Q. I have heard people have a tendency to fiddle with their implanted pumps. Does this pose any problems? A: Do not manipulate or rub the pump or catheter through the skin; this is sometimes called Twiddler’s Syndrome. Manipulation can cause component damage; catheter disconnection, kinking, or dislodgement; or skin erosion. Damage to the components of your infusion system can require surgery to repair or replace the components. Catheter disconnection and kinking can result in drug or spinal fluid leakage into tissue and tissue damage, or a loss of or change in therapy that can lead to serious injury or death. Manipulation may also cause the pump to flip over, making it impossible to refill the pump. Q: What are the side effects of the drugs used in my pump? A: Talk with your doctor about warnings and precautions regarding drug interactions, potential side effects, and signs and symptoms that require medical attention. Failure to recognize these signs and symptoms and to seek medical attention can result in serious injury or death. Q: What are the symptoms of drug overdose or drug withdrawal? A: Talk with your doctor about signs and symptoms of a drug overdose and underdose (withdrawal). Failure to recognize these signs and symptoms and to seek medical attention can result in serious injury or death. 14 Electromagnetic Interference (EMI) & How it May Affect the Pump Overview EMI stands for electromagnetic interference. Electromagnetic interference is a field of energy (electrical, magnetic, or a combination of both) made by equipment found in the home, work, medical environments, or public environments. The SynchroMed pumps have built-in features to protect them from EMI made by other equipment. Most of the magnetic and electrical devices normally encountered are unlikely to affect performance of the pump. However, sources of strong EMI can result in the following: • Patient injury, from heating of the implanted pump and damage to surrounding tissue. • System damage, from electrical or mechanical effects, resulting in loss of or change in therapy that can lead to serious injury or death. • Operational changes to the pump, from strong magnets temporarily stopping the pump motor or electrical interference causing a pump memory error, resulting in a loss of or change in therapy that can lead to serious injury or death. In the case of a pump memory error, reprogramming by your doctor will be required to confirm the pump is working properly. • Change in flow rate, from warming of the implanted pump, resulting in overinfusion and serious injury or death. Be sure to keep all household appliances in good working condition. If you suspect interference with your SynchroMed pump, move away from or turn off the electrical device. The pump will not be permanently affected. Note: EMI generally does not affect the IsoMed pump because the IsoMed pump does not contain any electronic circuitry, although EMI can heat the IsoMed pump, which may result in damage to surrounding tissue. The warming may also cause a change in flow rate, which could cause overinfusion and serious injury or death. 15 High-Magnetic-Field Devices Q: What should I do if electrical fields are affecting the pump? A: Testing indicates that the SynchroMed pump motor will stop while exposed to magnetic fields of 57 gauss or more at a distance of 5 cm (2 inches) or less. Less powerful magnets at closer distances may also stop the pump. Magnetic fields of 10 gauss or less will generally not affect the pump. Exercise care and avoid prolonged exposure to the following equipment or environments: • Electric arc welding equipment. • High-voltage areas (safe if outside the fenced area). • Magnets, degaussing equipment, and other equipment that generate strong magnetic fields. • Microwave communication transmitters (safe if outside the fenced area). • Television and radio transmitting towers (safe if outside the fenced area). If you think equipment is interfering with your pump, you should do the following: • Move away from the equipment or object. • Turn off the equipment or object, if possible. • Inform the equipment owner or operator what happened. If the above actions do not correct the effects of the interference, or if you think your therapy is not effective after exposure to EMI, you should contact your doctor. Note: Magnets may affect the pump motor. Also, they may cause a SychroMed II alarm to sound. IsoMed pump—Because the IsoMed pump does not contain any electronic circuitry, electrical devices will not normally affect it. SynchroMed pump (both the SynchroMed II and SynchroMed EL)—The SynchroMed pump has built-in features to protect it from interference produced by electrical devices found in the household. Under normal conditions, the household appliances you use in your daily activities will not affect the pump. 16 General Warnings & Precautions/ Medical Procedures & Equipment Overview Always tell healthcare professionals that you have an implanted pump before undergoing medical tests or procedures. Failure to tell healthcare professionals can result in procedural delays, damage to the implanted system requiring surgery to repair or replace the system, serious injury, or death. Bone growth stimulators — The coils of an external magnetic field bone growth stimulator should be kept 45 cm (18 in) away from the pump. After using either an implantable or external bone growth stimulator, your doctor should ensure the infusion system is working as intended. Cochlear Implant — If you have a cochlear implant, the external portion of the cochlear system should be kept as far away as possible from the clinician programmer or the cochlear implant should be turned OFF during programming to prevent unintended audible clicks. Defibrillation or Cardioversion — When you are in ventricular fibrillation, the first thought should be your survival. Testing indicates that external defibrillation is unlikely to damage the SynchroMed pump; however, if you have undergone external defibrillation, you should have your pump checked by your doctor to confirm that the pump is working as intended. Diathermy — Short wave diathermy should not be used within 30 cm (12 inches) of the pump or catheter. Energy from diathermy can produce a significant increase in temperature in the area of the pump and can continue to heat the tissue around the pump because the pump can retain heat. If overheated, a pump can deliver more than the prescribed amount of drug, potentially causing a drug overdose. The effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. High-Output Ultrasonic Devices/Lithotripsy — Do not use high-output ultrasonics or lithotripsy if you have an implanted infusion system. 17 Hyperbaric Treatment — Testing indicates that the pump should not be exposed to pressures above 2.0 atmospheres absolute (ATA). Pressures above 2.0 ATA could damage the pump, requiring surgery to replace the pump. To minimize damage to the pump when hyperbaric treatment is required, your doctor should fill the pump to the full level prior to hyperbaric treatment and maintain your typical pump prescription during hyperbaric treatment. As the pressure increases, pump flow decreases. Continuing to increase the pressure will eventually result in a loss of or change in therapy that could result in serious injury or death. Laser Procedures — The laser should be directed away from the infusion system. Magnetic resonance imaging (MRI) — Pump performance has not been established for Magnetic Imaging Resonance (MRI) scanners at fields greater than 1.5 T (Tesla) scanners. Patients with pumps should not have an MRI using these scanners. Your doctor will recommend whether or not an MRI is appropriate for you. The MRI will cause your pump to temporarily stop and suspend drug delivery during the MRI. The MRI may also cause your SynchroMed II pump to temporarily sound an alarm. This is normal with an MRI. The pump should resume normal operation after the MRI is complete. The effects of temporary suspension of medication will depend on the medication used in your pump. Your doctor will determine if alternative delivery methods for the drug should be used during the time required for the MRI and if medical supervision should be provided while the MRI is conducted. Your doctor should check your pump after an MRI to confirm your pump is still working properly. During an MRI, you may notice a warming sensation around the pump or feel a tingling sensation. If the warming or tingling sensation is uncomfortable to you, the MRI should be stopped and the settings adjusted to reduce or eliminate the sensation. During an MRI, you may also notice a slight tugging sensation at the pump. An elastic garment or wrap will reduce the tugging sensation. Additionally, the metal in the pump may cause the MRI image to be distorted in the area around the pump. The MRI should be adjusted to minimize the image distortion. Exposure of IsoMed pumps to MRI fields of 1.5T (Tesla) has demonstrated no impact on pump performance and a limited effect on the quality of the diagnostic information. 18 Pacemakers and defibrillators or other active implanted devices (interaction with) — If you have a pump and another active implanted device (e.g., pacemaker, defibrillator, neurostimulator): • The radio-frequency signal used to program either device can reset or reprogram the other device. • The magnet in a cardiac programmer may temporarily stop the pump. To verify that inadvertent programming did not occur, clinicians familiar with each device should check the programmed settings of each device before you are sent home from the hospital and after either device is programmed (or as soon as possible after these times). Contact your doctor immediately if you notice symptoms that could be related to either device or to the medical condition treated by that device. Psychotherapeutic procedures — Safety has not been established for psychotherapeutic procedures using equipment that generates electromagnetic interference (e.g., electroconvulsive therapy, transcranial magnetic stimulation) in patients who have an implanted infusion system. Induced electrical currents may cause heating of the pump, resulting in overinfusion and serious injury or death. Radiation Therapy — High radiation sources, such as cobalt 60 or gamma radiation, should not be directed at the pump. If radiation therapy is required near the pump, lead shielding should be placed over the pump to help prevent damage to the pump. Radio-frequency (RF) or microwave ablation — Safety has not been established for RF or microwave ablation in patients who have an implanted infusion system. Induced electrical currents may cause heating of the pump, resulting in overinfusion and serious injury or death. Therapeutic magnets (e.g., magnetic mattresses, blankets, wrist wraps, elbow wraps) – Keep therapeutic magnets at least 25 cm (10 in) away from your pump. Magnetic fields of 10 gauss or less will generally not affect the pump. 19 Other medical procedures – EMI from the following medical procedures is unlikely to affect your pump: • Computerized Axial Tomography (CT or CAT) scans. • Diagnostic ultrasound (e.g., carotid scan, doppler studies) Note: to minimize potential image distortion, the transducer must be kept 15 cm (6 in) away from the infusion system. • Diagnostic x-rays or fluoroscopy. • Electrocautery. • Magnetoencephalography (MEG). • Positron Emission Tomography (PET) scans. 20 Other Important Information Patient Identification Card • Your doctor will give you a temporary patient identification card. The card should be filled out and carried with you at all times. Patients in the United States will also receive a permanent patient identification card from Medtronic after the hospital sends Medtronic the device information. • In case of an emergency, the card will give those attending to you information about your pump, the doctor’s name, and important phone numbers. If you lose the patient identification card or need to change information on the existing card, call Medtronic at 1-800-510-6735 (in the U.S.) or contact your doctor if you are out of the U.S. When to Call the Doctor Call your doctor’s office if: • The pump alarm sounds. • You notice any swelling, redness, or pain near your incision. • You notice any unusual reaction to the specific medication you are receiving, or any unfamiliar side effects. The pump should be removed before burial or cremation. In some countries, removal of battery-powered implantable devices is mandatory before burial because of environmental concerns. Also, the pump should be removed before cremation because the cremation process causes the pump to explode. Explanted devices should not be resterilized or reimplanted. 21 Activities/ Common Questions About the Pump Q: Is it OK to exercise? A: Avoid activities that put undue stress on the implanted components of your infusion system. Activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching can damage the pump or catheter or cause the catheter to dislodge. This can require surgery to repair or replace the pump or catheter. The catheter could also become kinked or blocked, preventing drug delivery and resulting in a loss of or change in therapy that can lead to serious injury or death. Q: Can I drive? A: Your doctor will be able to provide information about the effects and side effects from the medication and how they may affect your ability to drive a vehicle. Q: Can I travel? A: Notify your clinician of any travel plans. Clinicians need this information to coordinate your care and pump refills, and prevent a loss of or change in therapy that could lead to serious injury or death. Q: Should I avoid long airline flights or high-altitude activities such as skiing or hiking in the mountains? A: Before engaging in activities at high altitudes (such as airline flights, skiing or hiking in the mountains), discuss the effects of low pressure with your doctor. Patients who live or travel at high altitudes are exposed to lower air pressures. With continued exposure to lower pressure, the flow rate of the pump may increase and then stay at the higher rate. If your doctor determines that such an increase in flow rate might pose an undue risk to you, your doctor can adjust your infusion prescription to offset this higher flow rate. In rare cases, exposure to the lower pressures can cause the flow rate of the SynchroMed II pump to exceed the programmed flow rate by more than 14.5% (15% for SynchroMed EL pumps and 25% for IsoMed pumps) while the patient is exposed to the lower pressure. The infusion prescription in SynchroMed pumps can be changed for patients who will be exposed to lower pressures. 22 Q: Will my pump set off metal detectors like the ones at the airport? A: Your pump may set off metal detectors at places like the airport, malls, schools, libraries, and other locations where metal detectors, theft detectors, or security devices are present. When approaching these devices, do not linger near or lean on the security screening device. Should you set off a metal detector/screening device, show your patient identification card to security personnel. Q: Will the use of a cellular phone affect the pump? A: Your pump is protected from low-powered stray electromagnetic interference (EMI) that is present in a typical cellular phone. However, if your phone is near your pump (1 meter), be sure to turn your phone OFF prior to any telemetry on your pump to help prevent EMI. Some cellular phones (not all kinds) contain a tiny magnet. Also, the type of phone that vibrates has a tiny motor that generates a small magnetic field. Q: Will people be able to see that I have a pump? A: On occasion someone might notice your pump under fitted clothes. Depending on your size and shape and where your pump is located, it might not show at all. Your pump is placed near the surface of your skin for easy refill access and might be visible if not covered with clothes. Q: Will I be able to take baths or showers? A: Talk with your doctor to find out if you may shower immediately following surgery. You should not soak in a bath until after your stitches are removed and your incisions are healed. After the incisions are healed, a bath that is less than 39˚C (102˚F) will not affect your pump. Q: Can I go in a hot tub, steam room, sauna, or tanning bed? A: If the temperature of the hot tub, steam room, sauna, or tanning bed is greater than 39˚C (102˚F), you should not use it. The flow rate of the pump will vary with body temperature. The flow rate increases as the temperature increases. If the increase is significant, the pump can deliver too much medication. This may lead to serious injury or death. Q. Can I go SCUBA diving? A: Do not dive below 10 meters (33 feet) of water. Pressures below 10 meters (33 feet) of water could damage the pump requiring surgery to replace the pump. As the pressure increases, pump flow decreases. Continuing to increase the pressure will eventually result in a loss of or change in therapy that could result in serious injury or death. 23 Q: Will the pump cure my condition? A: The pump will not eliminate the primary source of your condition or cure your disease. It will help you manage your symptoms and might allow you to participate in some activities that you were unable to do before. The infusion system might be one of several therapies your doctor uses to treat your condition. Q: Can I stop taking other medications once I have a pump? A: Your doctor will determine if you still need to take other medications. Q: What can cause a catheter dislodgment or tear? A: You should know where the catheter is implanted and keep in mind which movements may stretch or put strain on the catheter or on the stitches that hold the pump in place. Catheters become dislodged primarily because of certain motions or sudden or repetitive movements. Exercise and other activities should be approached with caution. Exercise or repetitive bending, twisting, bouncing, or stretching can move or stretch the catheter. A catheter can tear because of a nick caused by a suture during surgery or by rubbing on your bones. Although the catheter is made of flexible and durable materials, it is still subject to wear. Therefore, seemingly harmless or repetitive movements can cause unseen damage over time, eventually causing a tear or dislodgment. This damage may require surgery to repair the catheter. Contraindications/Risks An infusion system should not be implanted if: • You have an infection, meningitis, ventriculitis, skin infection, bacteremia, or septicemia. • The pump cannot be implanted 2.5 cm (1 inch) or less from the surface of the skin. (Health care personnel need access to the pump for refills.) • You do not have sufficient body size to accept the pump bulk and weight. • You have spinal anomalies that complicate placement of the catheter. 24 Surgical Risks Implanting an infusion system has risks similar to other surgical procedures, including pain or an infection at the implant site after surgery. Implanting an infusion system that will deliver drug to your spine has risks similar to spinal procedures, including: • Bruising • Bleeding • Swelling • Infection • Spinal fluid leak • Headaches • Paralysis Device Risks Some possible system complications related to the pump and catheter include: • The catheter or pump could migrate within the body or erode through the skin. • There could be undesirable changes in therapy, possibly related to cellular changes around the catheter tip. • The catheter could leak, tear, or become disconnected, resulting in delivery of medication into the area under the skin where the pump is implanted or along the catheter path. • The catheter could kink or become blocked resulting in no delivery of medication. • The pump could stop because it has reached end of service life or because of a component failure. These complications can require surgery to replace the pump or catheter, and can result in tissue damage or a loss of or change in therapy, which may lead to a return of underlying symptoms, drug withdrawal symptoms, serious injury, or death. Please be sure to ask your doctor or nurse about things that concern you or that you do not understand. 25 Battery and Alarms SynchroMed II Pump Battery and Alarms— FAQs Q: How long will the battery last? A: The battery is expected to last 7 years, depending on how much medication the pump is expected to deliver. Q: Are there different types of alarms in the SynchroMed II pump? A: Yes. There are two types of alarms: critical and non-critical. • Critical alarms are two-tone alarms. A critical alarm requires immediate physician attention. • Non-critical alarms are single-tone alarms. • During a clinic visit, the doctor will check the pump/alarms and manage any problems. Q: What triggers a critical alarm in the SynchroMed II pump? A: A critical alarm sounds if: • The pump has calculated that it has run out of medication. • The battery has reached the end of service (EOS). • There is a problem with the pump, such as a motor stall. • The pump is stopped for longer than 48 hours. • There is a pump memory error. If you hear a critical alarm (a two-tone alarm), contact your physician immediately. Q: What triggers a non-critical alarm in the SynchroMed II pump? A: A non-critical alarm sounds if: • The pump has calculated that the medication is running low and it’s time to refill your pump. • It’s time for replacement of your pump (this alarm occurs approximately 90 days before your pump reaches end of service). • There is a non-critical pump memory error. Also, notify your physician if you hear a non-critical alarm (a singletone alarm). A non-critical alarm is not as urgent as a critical alarm, but it still requires attention by your doctor. 26 Q: How will I know if the battery in my SynchroMed II pump is about to run out? A: The SynchroMed II pump has an elective replacement indicator (ERI) alarm. This alarm sounds when your pump is nearing End of Service (EOS). When the ERI alarm sounds, contact your doctor to schedule a pump replacement. If the pump is not replaced after the ERI alarm sounds, the pump will continue to operate for a while, but will stop after 90 days. A stopped pump results in a loss of therapy that can lead to serious injury or death. Q: How will I know if the medication in my SynchroMed II pump is about to run out? A: It is very important that you keep all of your scheduled refill appointments. Do not wait to hear an alarm before having your pump refilled. You will hear a non-critical (single-tone) alarm when the reservoir in the pump has calculated that it has reached the low-reservoir limit. Once an empty reservoir limit is reached, your pump will deliver a critical (two-tone) alarm. It is important that you maintain an adequate level of medication in the pump, or drug withdrawal symptoms may occur. SynchroMed EL Pump Battery and Alarms—FAQs Q: How long will the battery last? A: The SynchroMed EL pump is expected to last 5–7 years, depending on the flow rate. Q: How will I know when the battery in the pump is about to run out? A: The SynchroMed EL pump has a Low Battery Alarm that sounds when the pump battery is nearing depletion (the pump End of Service or EOS). When a pump alarm sounds, contact your doctor to determine the reason for the alarm and, if necessary, schedule a pump replacement. If the pump is not replaced shortly after the Low Battery Alarm sounds, the battery may become completely depleted, causing the pump to stop. A stopped pump results in a loss of therapy that can lead to serious injury or death. 27 Q: If the low-battery alarm is sounding, how long do I have before the battery is fully depleted? A: Many people are surprised at how soft the SynchroMed EL alarm is and may not hear it when it initially starts. Other times, the person does not hear it at all. For this reason, we recommend scheduling a pump replacement as soon as a low-battery alarm is confirmed by the doctor. If this is not possible, your doctor may prescribe oral medications as a precaution. The oral medication may supplement your other medical treatment and is meant to help prevent withdrawal symptoms in the event that your pump stops working before it is replaced. Q: Does the SynchroMed EL alarm always indicate a battery nearing depletion? A: No. The pump alarm may indicate that the pump needs refilling or that there is a pump memory error (see below). If the pump needs refilling, a “low-reservoir” alarm will sound. The alarm also may temporarily sound if the drug was not warmed to body temperature before the pump was filled. This alarm is a single beep. If you hear any alarm, contact your doctor immediately. If you hear the alarm for more than a few minutes, call your doctor to identify and correct the situation. During the clinic visit, your doctor will check the pump and manage any problems. Q: Is there an alarm to indicate that there is a problem with the pump? A: Yes. If there is a pump memory error, the pump will sound a doublebeep alarm. A pump memory error may occur if the pump memory is compromised by a strong magnetic force or other circumstances (see information on EMI on page 15). Once activated, each alarm occurs at specific intervals until your doctor shuts the alarm off with the programmer. Under certain circumstances the pump alarm may intermittently sound. This could indicate that your battery is nearing depletion. If an intermittent alarm occurs, contact your doctor immediately. If you notice a change in your condition, even if you don't hear an alarm, contact your doctor immediately to ensure the pump is working as intended. Q: What else should I be aware of? A: During a clinic visit, your doctor will check the pump/alarm and manage any problems. 28 IsoMed Battery/Alarms FAQs Q: Does the IsoMed pump have a battery or alarms? A: No, the IsoMed pump does not have a battery or alarms. It is powered by an inert gas. Unless there are complications with the pump mechanism or your medical condition, the pump may not need to be replaced. However, problems with the catheter could result in the need for surgery to replace or repair the catheter. If you experience a change in your condition before your next scheduled refill, contact your doctor. 29 Precautions Inflammatory mass at intraspinal catheter tip—An inflammatory mass that can result in serious neurological impairment, including paralysis, can occur at the tip of the implanted catheter. If you are on intraspinal opioid therapy for pain management, you should be monitored carefully at each doctor visit for any new neurological signs or symptoms. Your doctor should routinely monitor you for the following signs or symptoms of inflammatory mass: • Change in the character, quality, or intensity of your pain. • Unfamiliar or new pain, especially at or near the catheter tip. • Need for frequent or large increases of your daily drug dose to maintain the same effect. • Dose increases relieve your increasing pain only temporarily. To prevent possible permanent neurological injury, your doctor should immediately evaluate you if you develop the following signs or symptoms: • New or different sensory symptoms (e.g., numbness, tingling, burning, hyperesthesia [increased sensitivity to touch], hyperalgesia [increased sensitivity to pain]). • New, occasional, or intermittent bowel or bladder problems. • New motor weakness, change in gait, or difficulty walking. • Any neurological symptoms or signs that differ from normal (e.g., change in reflexes). 30 Glossary Catheter—A thin flexible tube that connects to the pump. The pump delivers medication through the catheter to a site in the body where it can have the best effect. Catheter access port (CAP)—The doctor uses the catheter access port to deliver medications or sterile solutions directly into the catheter, without going through the pump. The doctor might also use the catheter access port for some diagnostic purposes, such as testing to make sure medication is able to flow through the length of the catheter. Cerebrospinal fluid—The fluid surrounding the spinal cord. Defibrillation—The process of restoring normal rhythm to the heart, usually induced by a brief electric shock. Diathermy—The therapeutic heating of body tissues using electromagnetic radiation, electric currents, or ultrasonic waves. Diathermy is frequently used to promote muscle relaxation. Electrocautery—An instrument for directing high-frequency electric current through tissue. FAQs—Frequently asked questions. Interrogate—The act of getting information from the pump using telemetry via radio frequency signals. Intrathecal infusion/intrathecal drug delivery—The delivery of medication directly to the intrathecal space. This type of therapy can be administered with a fully implantable drug infusion system. Intrathecal space—The fluid-filled space that surrounds the spinal cord. IsoMed Constant-Flow Infusion System—A fully implantable drug infusion system that delivers drug at a fixed-flow rate. Lithotripsy— The crushing of a stone in the renal pelvis, ureter, or bladder, by mechanical force or focused sound energy. Magnetic Resonance Imaging (MRI)— A non-xray imaging technique that uses magnetic fields and radiofrequency waves to visualize anatomic structures. 31 Medtronic—The world’s leading medical technology company, dedicated to providing lifelong solutions for people with chronic disease. Among other products, Medtronic designs and manufactures the SynchroMed and IsoMed Infusion Systems. Patient identification card—A wallet-sized card that indicates the type of Medtronic device a person has implanted, the product’s serial number, emergency contact information, and other pertinent information. Programmer—A device a doctor or nurse uses to adjust the amount of medication the SynchroMed pump delivers. The programmer communicates with the pump using radio waves (telemetry). Pump—The round metal device that stores and delivers the medication. Reservoir—The cavity inside the pump where the medication is stored. Reservoir fill port—The port in the pump that the doctor uses to fill the pump. A special needle is inserted through the skin and fills the reservoir with medication. Septum—The self-sealing, rubber part of the pump through which a special needle is inserted during refills of the pump. SynchroMed Infusion System—Consists of an external programmer and an implanted pump and catheter. The implanted pump and catheter deliver medication to the area in the body where it can have the best effect. Telemetry—The interchange of information, via a two-way radio frequency link, between the SynchroMed pump and the programmer. 32 SynchroMed® II Drug Infusion System Brief Summary: Product technical manual and the appropriate drug labeling must be reviewed prior to use for detailed disclosure. Indications: Chronic intraspinal (epidural and intrathecal) infusion of preservativefree morphine sulfate sterile solution (and preservative-free morphine hydrochloride outside of the United States) in the treatment of chronic intractable pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity; chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Contraindications: When infection is present; when the pump cannot be implanted 2.5 cm or less from the surface of the skin; when body size is not sufficient to accept pump bulk and weight; when contraindications exist relating to the drug. Warnings: Comply with all product instructions for initial preparation and filling, implantation, programming, refilling, and injecting into the catheter access port (CAP) of the pump. Failure to comply with all instructions can lead to technical errors or improper use of implanted infusion pumps and result in additional surgical procedures, a return of underlying symptoms, or a clinically significant or fatal drug under- or overdose. Refer to the appropriate drug labeling for specific under- or overdose symptoms and methods of management. Avoid using short wave (RF) diathermy within 30 cm of the pump or catheter. Diathermy may produce significant temperature rises in the area of the pump and continue to heat the tissue in a localized area. If overheated, the pump may over-infuse the drug, potentially causing a drug overdose. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. An inflammatory mass that can result in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients on intraspinal opioid therapy carefully for any new neurological signs or symptoms. For intraspinal therapy, use only preservative-free sterile solution indicated for intraspinal use. Use only Medtronic components indicated for use with this system. Failure to firmly secure connections can allow drug or cerebrospinal fluid (CSF) leakage into tissue and result in tissue damage or inadequate therapy. A postoperative priming bolus should not be programmed if the pump is a replacement and the catheter has not been aspirated. Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage, and administration information, and screening procedures. Physicians must be familiar with the drug stability information in the technical manual and must understand the dose relationship to drug concentration and pump flow rate before prescribing pump infusion. Implantation and ongoing system management must be performed by individuals trained in the operation and handling of the infusion system. Inform patients of the signs and symptoms of drug underdose or overdose, appropriate drug warnings and precautions regarding drug interactions, potential side effects, and signs and symptoms that require medical attention. Instruct patients to notify their clinician of travel plans, to return for refills at prescribed times, avoid activities such 33 as strenuous exercise or contact sports that jar, impact, twist, or stretch the body, to always carry their Medtronic device identification card, to avoid manipulating the pump through the skin, and to notify healthcare professionals of the implanted pump before medical tests/procedures. Patients must consult their physician before engaging in activities involving pressure or temperature changes (e.g., scuba diving, saunas, hot tubs, hyperbaric chambers, flights, skydiving, etc.). Inform patients that the pump has an Elective Replacement Indicator (ERI) that sounds when the pump is nearing its end of service. When the alarm sounds, patients must contact their doctor to schedule pump replacement. Precautions: The pump is ethylene oxide sterilized. Do not use if the product or package is damaged, the sterile seal is broken, or the “Use By” date has expired. Do not reuse or resterilize the pump; it is intended for “single use only.” Do not expose the pump to temperatures above 43°C or below 5°C. Consider use of peri- and post-operative antibiotics for pump implantation, for any subsequent surgical procedure, or if infection is present. For patients prone to CSF leaks, clinicians should consider special procedures, such as a blood patch. Follow instructions for emptying and filling the pump during a replacement or revisions that require removal of the pump from the pocket. Explant the pump postmortem if incineration is planned (to avoid explosion), or if local environmental regulations mandate removal. Return explanted devices to Medtronic for analysis and safe disposal. Do not implant a pump dropped onto a hard surface or showing signs of damage. Implant the pump less than 2.5 cm from the surface of the skin. Ensure pump ports will be easy to access after implant, that the catheter is not kinked and secured well away from pump ports before suturing. Keep the implant site clean, dry, and protected from pressure or irritation. If therapy is discontinued for an extended period of time, fill the reservoir with preservative-free saline in intraspinal applications or appropriate heparinized solution (if not contraindicated) in vascular applications. The magnetic field or telemetry signals produced by the programmer may cause sensing problems and inappropriate device responses with an implantable pacemaker and/or defibrillator. Electromagnetic interference (EMI) is an energy field generated by equipment found in the home, work, medical, or public environments. Most EMI normally encountered will not affect the operation of the pump. Exceptions include: injury resulting from heating of the pump which can damage surrounding tissue (diathermy, MRI), system damage which can require surgical replacement or result in loss/change in symptom control (defibrillation, electrocautery, high-output ultrasonics, radiation therapy), and operational changes to the pump causing the motor to stop, loss of therapy, return of underlying symptoms, and require confirmation of pump function (diathermy, high magnetic field devices, hyperbaric/hypobaric conditions, magnetic resonance imaging (MRI)). MRI will temporarily stop the pump motor’s rotor due to the magnetic field of the MRI scanner and suspend drug infusion during MRI exposure which will cause the pump alarm to sound. The pump should resume normal operation upon termination of MRI exposure. Prior to MRI, the physician should determine if the patient can safely be deprived of drug delivery. If not, alternative delivery methods for the drug can be utilized during the MRI scan. Prior to scheduling an MRI scan and upon its completion, pump status should be confirmed. Adverse Events: Include, but are not limited to, cessation of therapy due to end of device service life or component failure, change in flow performance due to component failure, inability to program the device due to programmer failure, CAP 34 component failure; inaccessible refill port due to inverted pump, pocket seroma, hematoma, erosion, infection, post-lumbar puncture (spinal headache), CSF leak, radiculitis, arachnoiditis, bleeding, spinal cord damage, meningitis (intrathecal applications), anesthesia complications, damage to the pump, catheter and catheter access system due to improper handling and filling before, during, or after implantation; change in catheter performance due to catheter kinking, disconnection, leakage, breakage, occlusion, dislodgement, migration, or catheter fibrosis; body rejection phenomena, surgical replacement of pump or catheter due to complications; local and systemic drug toxicity and related side effects, complications due to use of unapproved drugs and/or not using drugs in accordance with drug labeling, or inflammatory mass at the tip of the catheter in patients receiving intraspinal morphine or other opioid drugs. CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. Medtronic® SynchroMed® and IsoMed® Infusion Systems Product technical manual and the appropriate drug labeling must be reviewed for detailed disclosure prior to use. Indications: US: Chronic intrathecal infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain and chronic intravascular infusion of floxuridine (FUDR) for the treatment of primary or metastatic cancer. SynchroMed is also indicated for chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for severe spasticity, chronic epidural infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, chronic intravascular infusion of doxorubicin, cisplatin, or methotrexate for the treatment of primary or metastatic cancer, and chronic intravenous infusion of clindamycin for the treatment of osteomyelitis. Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling. Contraindications: When infection is present except when indicated for the treatment of osteomyelitis; when the pump cannot be implanted within 2.5 cm (1 inch ) from the surface of the skin; when body size is not sufficient to accept pump bulk and weight; when contraindications exist related to the drug. Blood sampling through the side catheter access port is contraindicated. Warnings: Use only with approved drugs. Improper use, calculation or programming errors, or component failure may result in loss of therapeutic effect, or clinically significant or fatal drug overdose or underdose symptoms. Clinically significant or fatal drug overdose may result from overpressurization of the pump reservoir, overheating of the pump during implant preparation or as a result of diathermy, improper pump preparation, improper injection of drug through the catheter access port or into the pump pocket, or failure to account for significant amounts of drug residing in the reservoir, pump tubing, catheter access port, or catheter. The effects of mixing drugs are unknown. Flow rate of the IsoMed pump may decrease or stop if drug precipitation occurs. An inflammatory mass that can result in serious neurological impairment, including paralysis, can occur at the tip of the implanted catheter. Patients on intraspinal opioid therapy should be monitored carefully at each visit for any new 35 or changed neurological signs or symptoms. Timely treatment may minimize or avert permanent neurological injury. The effects of implanting the SynchroMed pump in patients with other implanted programmable devices are unknown. Do not use if sterility has been compromised or if the use by date has expired. Do not resterilize or reuse. Precautions: Only qualified personnel should implant, fill and refill the pumps; access the catheter access ports; or program the SynchroMed pump. Follow recommended procedures. Maintain strict aseptic techniques during all procedures to prevent infection. The catheter access port does not contain a bacterial filter. Consider use of peri- and postoperative antibiotics for pump implantation and any subsequent surgical procedures. Use caution in selecting an anatomical pump site appropriate to the size and mass of the patient. Initial fill and refill volumes must not exceed levels specified in the technical manuals. Do not allow pump to stop or run dry; if therapy is discontinued, maintain minimal flow of appropriate fluid. Do not expose pumps to temperatures above 43 degrees C (110 degrees F) or below 5 degrees C (40 degrees F). Avoid exposing pump to diathermy, therapeutic radiation, lithotripsy or pressure extremes. Do not implant a pump that has been dropped onto a hard surface or shows signs of damage. Follow manufacturer’s instructions regarding drug preparation, dosage, and administration. FUDR should be used with added caution in patients with impaired hepatic or renal function. Systemic therapy should be considered for patients with known disease extending beyond an area capable of infusion. IsoMed pump flow rate will vary depending on factors such as body temperature, altitude, arterial pressure at the catheter tip, and solution viscosity. Advise patients of symptoms to report, activities to avoid, and the importance of keeping refill appointments. Magnetic Resonance Imaging (MRI): MRI will temporarily stop the SynchroMed pump motor and suspend drug infusion for the duration of MRI exposure. The SynchroMed pump should resume normal operation upon termination of MRI exposure. Exposure of IsoMed pumps to MRI fields of 1.5 T (Tesla) has demonstrated no impact to pump performance and a limited effect on the quality of the diagnostic information. During an MRI scan, the patient may experience heating or peripheral nerve stimulation at or near the pump implant site. In the unlikely event that this happens, the MRI scan parameters should be adjusted to reduce Specific Absorption Rate (SAR) for heating or dB/dt for nerve stimulation or both. Upon completion of an MRI scan, the SynchroMed pump parameters should be confirmed using a Medtronic clinician programmer. SynchroMed pump performance has not been established in >2.0 T (Tesla) MR scanners nor has IsoMed pump performance been established in >1.5 T (Tesla) MR scanners - it is not recommended that patients have MRI scans using these scanners. Adverse Events: Include, but not limited to, clinically significant or fatal drug overdose or underdose, cessation or change in therapy, or a return of underlying symptoms due to an empty reservoir, component failure, misuse, misprogramming or miscommunication, or SynchroMed battery depletion; seroma/hematoma, infection, inflammation, tissue erosion, or pain at implant site; complete or partial catheter occlusion, kinking, breakage, leakage or disconnection; catheter dislodgment or migration; CSF leak/accumulation, internal/GI bleeding; arachnoiditis; radiculitis; meningitis; spinal headache; inflammatory mass; perforation of internal organs; drug toxicity and related side effects; and procedural complications. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. 36 Refill Schedule January 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 February 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 March 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 April 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 May 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 June 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 July 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 August 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 September 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 October 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 November 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 December 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 37 United States of America Medtronic Neurological 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Internet: www.medtronic.com Tel. 763-505-5000 Fax 763-505-1000 Toll-free 1-800-328-0810 Europe Medtronic Europe S.A. Route du Molliau 1131 Tolochenaz Switzerland Internet: www.medtronic.co.uk Tel. +41-21-803-8000 Fax +41-21-803-8900 Asia-Pacific Medtronic International, Ltd. Suite 1602 16/F Manulife Plaza The Lee Gardens, 33 Hysan Avenue Causeway Bay Hong Kong Tel. 852-2891 4456 Fax 852-2891-6830 Canada Medtronic of Canada Ltd. 6733 Kitimat Road Mississauga, Ontario L5N 1W3 Canada Tel. 1-905-826-6020 Fax 1-905-826-6620 Australia Medtronic Australasia Pty. Ltd. Unit 4/446 Victoria Road Gladesville NSW 2111 Australia Tel. 02-9879-5999 Fax 02-9879-5100 Toll-free 1-800-251-760 UC199603123c EN NP2686c © Medtronic, Inc. 2005 All Rights Reserved Printed in USA