Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Emergency psychiatry wikipedia , lookup
Obsessive–compulsive personality disorder wikipedia , lookup
History of psychiatric institutions wikipedia , lookup
Controversy surrounding psychiatry wikipedia , lookup
Psychosurgery wikipedia , lookup
Psychedelic therapy wikipedia , lookup
Abnormal psychology wikipedia , lookup
Medtronic Confidential NeuroPatntRXX 3391_ENFC.fm 4/25/11 10:41 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN YOUR RECLAIM® DBS™ THERAPY FOR OCD Therapy-specific Patient Booklet Patient Manual Rx Only Humanitarian Device: Authorized by Federal (U.S.A.) law for use as an adjunct to medications and as an alternative to anterior capsulotomy for the treatment of chronic, severe, treatment-resistant obsessivecompulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). The effectiveness of this device for this use has not been demonstrated. MA10554A004 Rev X Printing instructions: 3391_ENFC.fm 4/25/11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic Confidential NeuroPatntRXX Medtronic® and Reclaim® are trademarks of Medtronic, Inc., registered in the U.S. and other countries. DBS™ is a trademark of Medtronic, Inc. MA10554A004 Rev X Printing instructions: 3391_ENIntro.fm 4/25/11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Information for family members or caregivers Read this patient manual thoroughly so you can assist the patient living with Reclaim DBS Therapy. The patient should have two patient therapy manuals. If you do not have both manuals, contact the patient’s doctor. Always tell any medical personnel that the patient has an implanted brain stimulator and tell them where it is located. If medical personnel have any questions, they should contact Medtronic at 1-800-510-6735. Have the name and telephone number of the patient’s doctor at hand if you have any questions or problems. Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 3 3391_ENIntro.fm 4/25/11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 4 2011-07 MA10554A004 Rev X Medtronic ConfidentialNeuroPatntR00 Reclaim DBS Therapy for OCD Medtronic ConfidentialNeuroPatntR00 3391_ENTOC.fm 4/25/11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Contents Glossary 7 Manual descriptions 13 Reclaim DBS System for OCD Benefits and limitations 16 Description of the device Risks 15 17 19 Warnings 20 Precautions 21 Possible side effects 23 Expected battery life 25 What to expect from your implant procedure 26 Before surgery 26 Details of your DBS surgery 26 Changes in therapy 29 Control devices 30 Use in specific populations Index 31 35 Reclaim DBS Therapy for OCD 2011-07 MA10554A004 5 3391_ENTOC.fm 4/25/11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 6 Medtronic ConfidentialNeuroPatntR00 2011-07 Reclaim DBS Therapy for OCD MA10554A004 3391_EN_Ch1_Gloss.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Glossary Battery – A part of the neurostimulator that provides the power for your brain stimulation system. Neurostimulator service life depends on individual use. Capsulotomy – A surgical technique that is intended to lessen the symptoms of obsessive-compulsive disorder that involves the destruction of specific groups of cells within a place in the brain called the internal capsule. Clinician programmer – A small computer that is used to program the Reclaim DBS System. The doctor can change the therapy settings using this programmer. Cognitive behavior therapy (CBT) – Psychotherapy that emphasizes the substitution of undesirable thinking patterns with desirable thinking patterns. Comorbid psychiatric disorder – A psychiatric disorder that exists simultaneously with and usually independently of another psychiatric disorder. Reclaim DBS Therapy for OCD 2011-07 M926004A013 Rev X 7 3391_EN_Ch1_Gloss.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Control magnet – A magnet used to turn your neurostimulator on and off. Disinhibition – The lessening of inhibition that results in behavior not normally engaged in that may go beyond accepted cultural norms. Electroconvulsive therapy (ECT) – Therapy that uses electrodes placed on the outside of the head to send electric current to the brain for the treatment of certain mental disorders. Also called electroshock therapy. Electrode – A metal piece near the tip of the lead. Electrodes deliver electrical pulses to an area of your brain that may alter the way you feel. Electromagnetic interference (EMI) – Electrical or magnetic energy that is strong enough to interfere with or disrupt your therapy. Explant – The removal of an implanted device. Explantation requires surgery. Hypomania – A mild form of mania, characterized by hyperactivity or euphoria. 8 2011-07 Reclaim DBS Therapy for OCD M926004A013 Rev X 3391_EN_Ch1_Gloss.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Inappropriate euphoria – Feeling very good even when it isn’t justified. Lead – A thin wire with protective coating that has metal electrodes on one end. The electrodes are placed in your brain and the other end of the lead is connected to the DBS system extension. Neurostimulator – The neurostimulator is the implanted device that generates and controls your DBS therapy. Paraphilias – Psychosexual disorders characterized by deviant sexual thoughts or actions. Patient programmer – A hand-held device that allows you to turn your therapy on and off. It may also be used to adjust some stimulation settings. Service life – Amount of time that the device battery is expected to work based on the programmed parameters, clinician-selectable features, and how often the device is used by the patient. Somatic psychiatric therapies – Therapies such as electroconvulsive therapy (sometimes Reclaim DBS Therapy for OCD 2011-07 M926004A013 Rev X 9 3391_EN_Ch1_Gloss.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 called electroshock therapy), transcranial magnetic stimulation, or vagus nerve stimulation that may generate electromagnetic interference. Stimulation – The delivery of electrical signals to the brain cells. The electrical signals may alter some of the incorrect messages processed by the brain in the areas that control mood and anxiety. Stimulation target – The area of the brain where the application of stimulation is most effective. Surgical ablation – Surgical destruction of brain tissue intended to lessen the symptoms of obsessive-compulsive disorder. An example is a capsulotomy, which is an alternative to neurostimulation therapy. Test stimulation – The time period during the system implant procedure when brain stimulation is evaluated to determine how well it controls your symptoms. Therapy controller – An electronic remote control device used to turn your neurostimulator on and off. 10 2011-07 Reclaim DBS Therapy for OCD M926004A013 Rev X 3391_EN_Ch1_Gloss.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Reclaim DBS Therapy for OCD 2011-07 M926004A013 Rev X 11 3391_EN_Ch1_Gloss.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 12 Medtronic ConfidentialNeuroPatntR00 2011-07 Reclaim DBS Therapy for OCD M926004A013 Rev X 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Manual descriptions There are two Medtronic DBS Therapy manuals for OCD patients that you should receive from your doctor. • The DBS Patient Therapy Guide, which contains information about all DBS therapies. • The DBS Therapy-specific Patient Booklet, which contains important DBS therapy information specific to the patient’s condition. The patient manual that describes Medtronic DBS Therapy includes general information about using the Medtronic DBS System. For example, information about Medtronic DBS System components, the implant procedure, life after surgery, and general risks and warnings applies to OCD patients as well as other patients receiving DBS therapy. It is important to review this information, in particular the section dealing with warnings and precautions. If you are a parent or caregiver of someone who has received a Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 13 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Reclaim DBS System, read this document and ensure the patient is adequately trained on the relevant issues, particularly those relating to general risks, warnings and precautions. The supplemental manual (the document you are currently reading) gives specific information related to using the Reclaim DBS System to treat OCD. It provides information that is not included in the patient manual describing Medtronic DBS Therapy with your implanted neurostimulator. You should also receive a patient manual instructing you how to operate your therapy controller or patient programmer, if your doctor prescribes either optional accessory for you. 14 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Reclaim DBS System for OCD Some of your symptoms are caused by abnormal messages being processed by your brain. Your brain stimulation system delivers mild electrical stimulation to an area in the brain that controls mood and anxiety. Stimulation alters some of the messages as they are being processed by the brain. This may relieve the symptoms of your disease. Your therapy helps you control symptoms. It is not a cure. When you turn on the brain stimulation system, it will deliver stimulation that may decrease your symptoms. Symptoms will return when the system is turned off. Significant OCD symptoms are likely to persist following Reclaim DBS Therapy. The brain stimulation system is one therapy that helps you control the symptoms of your disease. Other therapies and options include Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 15 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 cognitive behavior therapy (CBT), medication therapy, and capsulotomy. Benefits and limitations Reclaim DBS Therapy for OCD may help you manage your symptoms, but it is not a cure. Significant OCD symptoms are likely to persist following Reclaim DBS Therapy. When you turn on the brain stimulation system, it will deliver stimulation that may decrease some or all of your symptoms. The stimulation may also make it easier for you to engage in cognitive behavior therapy (CBT), which may also help control your symptoms. Your symptoms will probably return when the system is turned off. In some cases, symptoms may return with an intensity greater than was experienced prior to the system implant (See “Rebound effect” on page 21). You will continue to require medications to control your OCD. 16 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Description of the device Depending on your medical condition, you may have one or two neurostimulators implanted, which provide stimulation for the treatment of OCD. Your system consists of 2 leads and 2 extensions. Each lead connects to an extension and each extension connects to a neurostimulator. /HDGV /HDG([WHQVLRQ &RQQHFWLRQ ([WHQVLRQ ([WHQVLRQ 1HXURVWLPXODWRU &RQQHFWLRQ 1HXURVWLPXODWRU %DWWHU\ Figure 1 The implanted Reclaim DBS System (with 1 neurostimulator). Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 17 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 /HDGV /HDG([WHQVLRQ &RQQHFWLRQ ([WHQVLRQ ([WHQVLRQ ([WHQVLRQ 1HXURVWLPXODWRU &RQQHFWLRQ ([WHQVLRQ 1HXURVWLPXODWRU &RQQHFWLRQ 1HXURVWLPXODWRU %DWWHU\ Figure 2 The implanted Reclaim DBS System (with 2 neurostimulators). 18 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Risks Electroconvulsive therapy (ECT) – The safety of ECT in patients who have an implanted deep brain stimulation (DBS) system has not been established. Induced electrical currents may interfere with the intended stimulation or damage the neurostimulation system components resulting in loss of therapeutic effect, clinically significant undesirable stimulation effects, additional surgery for system explantation and replacement, or Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 19 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Warnings Side effects during programming or test stimulation – During test stimulation or a programming session, some side effects may occur, including: • facial flushing or facial muscle contractions • increased heart rate • hyperactivity or euphoria (hypomania) • increased disease symptoms Your doctor will select different stimulation settings until these side effects decrease. Because these side effects may not appear immediately, you may be asked to remain in the clinic for at least 30 minutes after your programming or test stimulation is complete. Note: For a complete list of warnings, see your DBS Patient Therapy Guide. 20 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Precautions Long-term safety and effectiveness – The long-term safety and effectiveness of brain stimulation therapy for obsessive-compulsive disorder has not been established. Rebound effect – If your brain stimulation system ceases to function for any reason (eg, battery depletion or exposure to EMI sources that will shut off the system), your symptoms will probably return. In some cases, symptoms may return with an intensity greater than was experienced prior to the system implant (rebound effect). If this occurs, contact your physician immediately so the status of your system can be assessed and your condition can be closely monitored. Somatic psychiatric therapies – The safety of somatic psychiatric therapies using equipment that generates electromagnetic interference (eg, vagus nerve stimulation) has not been established. Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 21 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Note: For a complete list of precautions, see your DBS Patient Therapy Guide. 22 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Possible side effects Side effects of brain stimulation may include the following: • Suicidal ideation and depression • Increased OCD symptoms • Changes in mood (positive and negative) • Increased anxiety • Gastrointestinal disturbances • Sensations such as tingling (paresthesia), smell, or taste • Dizziness or lightheadedness (disequilibrium) • Facial and limb muscle weakness or partial paralysis (paresis) • Facial flushing or facial muscle contractions • Jolting or shocking sensation • Numbness (hypoesthesia) • Increased heart rate Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 23 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 • Hyperactivity or euphoria (hypomania) Your doctor should carefully monitor you for symptoms of depression, anxiety, and/or hypomania/mania. Such symptoms may include changes in sleep or eating behavior, disinhibition, anger, aggression, and a predisposition to accidents. Note: Contact your doctor if you experience side effects such as inappropriate euphoria or disinhibition. There is also potential for brain tissue damage if the stimulation parameters are set too high. Your physician will be warned when the stimulation parameters exceed a certain charge density. 24 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Expected battery life Refer to your DBS Patient Therapy Guide for information on the expected battery life of your neurostimulator. Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 25 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 What to expect from your implant procedure The following is general information about how the Reclaim DBS System will be implanted. Your doctor can provide you with more specific information about your implant procedure. Before surgery The evening before surgery, you may be instructed to stop taking all or some of your medications. You will be admitted to the hospital either the night before or the morning of your surgery. You may have all or part of your head shaved prior to surgery to help prevent infection. Details of your DBS surgery During the surgery to implant your Reclaim System for OCD, your doctor will use the 26 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 following techniques to determine the area in your brain where the leads will be placed. – You will receive local anesthesia before this procedure. – Your surgeon may test stimulate areas of your brain to check changes in mood or anxiety levels (ie, OCD symptoms). You will be awake, but lightly sedated. This is so you can help determine, along with your doctor, when your symptoms are best controlled. Your doctor may ask you questions about your mood. – When the best target in the brain is located, the lead is then passed into the brain. Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 27 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Hole Cap Medtronic ConfidentialNeuroPatntR00 Stimulation Target Lead Electrodes Figure 3 The location of the lead in your brain. 28 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Changes in therapy There may be changes in the level of your symptom improvement over time. These changes may include: • Less relief or no symptom relief • Loss of effective stimulation Your clinician may correct these changes by programming the brain stimulation system again. However, surgery may be required to reposition or replace the lead, replace the system, or remove the system. You may also ask your doctor to turn off your neurostimulation system. Your condition may improve, may worsen, or may remain unchanged with stimulation. Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 29 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Control devices Your neurostimulator can be turned on or off using either a control magnet, a therapy controller, or a patient programmer. Your physician will determine which control device is appropriate for your needs. You will receive a booklet that tells you how to care and how to use your control device. Depending on your individual circumstance, you may have a sensory experience (tingling, smell, or taste), feel a slight muscle contraction, or experience no change at all. 30 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Use in specific populations The safety and probable benefit of this therapy is not known for: • Patients with Tourette’s syndrome • Patients with OCD with a primary subclassification of hoarding • Patients whose diagnosis of OCD is documented to be less than 5 years duration • Patients whose YBOCS score is less than 30 • Patients who have not completed a minimum of 3 adequate trials of first and/ or second line medications with augmentation • Patients who have not attempted to complete an adequate trial of cognitive behavior therapy (CBT) • Patients with a previous surgical ablation procedure (e.g., capsulotomy) Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 31 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 • Patients who are pregnant • Patients under the age of 18 years • Patients with dementia • Patients with coagulopathies or who are on anticoagulant therapy • Patients without comorbid depression and anxiety • Patients with neurological disorders • Patients with other serious medical illness including cardiovascular disease, renal or hepatic failure, and diabetes mellitus Use in patients with comorbid psychiatric disorders – There are potential risks with implanting the brain stimulation system in OCD patients who have comorbid psychiatric disorders that include: • bipolar disorder • body dysmorphic disorder • expanded personality impulse-control disorders or paraphilias 32 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 • psychotic disorder • severe personality disorders • substance abuse • the inability to control suicidal impulses or a history of suicidal attempts The brain stimulation system may aggravate the symptoms of comorbid psychiatric disorders. Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 33 3391_EN_Ch2_DescripInfo.fm 4/25/ 11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN 34 Medtronic ConfidentialNeuroPatntR00 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_ENIX.fm 4/25/11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Index B Brain stimulation possible side effects 23 precautions 21 warnings 20 Brain stimulation system picture of implanted system 17, 18 risks 19 C Caregivers, information for 3 Control devices 30 D Description brain stimulation system 17 Reclaim System 17 Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 35 3391_ENIX.fm 4/25/11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 G Glossary 7 L Lead placement in the brain 28 M Medical personnel informing of implant 3 Medtronic phone number for physicians 3 P Precautions 21 R Reclaim DBS Therapy changes in therapy 29 precautions 21 risks 19 warnings 20 36 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_ENIX.fm 4/25/11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Reclaim System description 17 picture of implanted system 17, 18 Risks possible side effects of brain stimulation 23 S Side effects of brain stimulation 23 Stimulation possible side effects 23 Stimulation target 28 Surgery before the procedure 26 details 26 medication 26 test stimulation at implant 27 Symptoms changes in 29 T Therapy changes in 29 Reclaim DBS Therapy for OCD 2011-07 MA10554A004 Rev X 37 3391_ENIX.fm 4/25/11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 W Warnings 20 38 2011-07 Reclaim DBS Therapy for OCD MA10554A004 Rev X 3391_ENbcv.fm 4/25/11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN MA10554A004 Medtronic ConfidentialNeuroPatntR00 3391_ENbcv.fm 4/25/11 10:42 am Size 4.625" x 6.0" (117 mm x 152 mm) UC200xxxxxx EN Medtronic ConfidentialNeuroPatntR00 Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432USA www.medtronic.com Tel. 1-763-505-5000 Toll-free 1-800-328-0810 Fax 1-763-505-1000 *MA10554A004* MA10554A004 © Medtronic, Inc. 2011 All Rights Reserved MA10554A004