Download Intrathecal Drug Delivery - Neurology Center of Wichita

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
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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