FREQUENTLY ASKED QUESTIONS DBS THERAPY FOR OCD

DOES DEEP BRAIN STIMULATION (DBS) CURE OCD?

There is no cure for obsessive-compulsive disorder* at this time. DBS Therapy may treat some of the symptoms of OCD but does not cure the underlying condition. If stimulation is discontinued, symptoms will likely return.

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WHAT ARE THE IMPLANTED COMPONENTS OF THE MEDTRONIC DBS SYSTEM?

The Reclaim™ DBS system consists of the following implanted components:

• Two leads implanted in the brain
• Two extensions threaded under the skin from the head, down the neck, and into the upper chest
• One or two neurostimulators implanted under the skin below the collarbone and connected to the extensions

Sometimes called a “brain pacemaker,” the neurostimulator produces the electrical signals needed for stimulation. These electrical pulses are delivered through the extension and lead to the targeted areas in the brain. The pulses can be adjusted wirelessly to check or change the neurostimulator settings.

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CAN OTHER PEOPLE SEE THE COMPONENTS OF THE SYSTEM?

Depending on your body build, the neurostimulator may be noticeable as a small bulge under the skin. It typically isn't noticeable under clothes. There also may be a slight bump on the top of your head, but it usually isn't visible under hair.

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WHAT IS THE TYPICAL LENGTH OF HOSPITALIZATION FOR TESTS, PROCEDURE, AND RECOVERY?

Most people spend a couple of days at the hospital. Healing can take several weeks. You will have pain medications for any discomfort you may have at the incision sites.

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DOES THE DBS SYSTEM MAKE ANY NOISE?

No.

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IS IT SAFE TO HAVE MEDICAL PROCEDURES WITH THE SYSTEM IMPLANTED?

Medtronic provides safe^† access to MRI anywhere on the body with some Medtronic DBS systems under certain conditions — giving your doctor an important tool for diagnosis. Some Medtronic DBS devices may remain on, when programmed to certain conditions, while you have an MRI. You may take comfort in knowing that the device can remain on (if programmed to the right settings) to control your symptoms. This may allow the quality of the image to be improved if the movement symptoms related to the disease are reduced.

You must inform the doctor who manages your Medtronic DBS Therapy that an MRI examination has been prescribed for you. Your doctor needs to determine what type of MRI scan you are eligible to receive. Depending on what kind of Medtronic DBS system components that you have implanted, you may be eligible for one of the following types of MRI scans:

• MRI scans of the head only (this is referred to as head-only eligible)
• MRI scans of any part of your body (this is referred to as full-body)

Before your MRI appointment always read the MRI examinations section of your patient manual.

Consult your doctor before engaging in any medical treatment or diagnostic test (for example, mammograms, electrocautery, MRI, or heart defibrillation). Electroconvulsive Therapy (ECT), Transcranial Magnetic Stimulation (TMS), and diathermy (deep heat treatment) should not be permitted under any circumstances. Refer to Important Safety Information.

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HOW IS THE STIMULATION ADJUSTED?

Your clinician programs your stimulation levels wirelessly. The process is a noninvasive way of adjusting stimulation to meet your symptom control needs.

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WHAT IS THE HISTORY OF DBS?

Medtronic started developing deep brain stimulation in 1987 and has been the leader in the field ever since. Your Medtronic DBS will be backed by our decades of research, innovation, and experience.

Medtronic DBS Therapy is currently approved to treat Parkinson's disease and essential tremor, and as a Humanitarian Device to treat dystonia and obsessive-compulsive disorder. Since 1997, more than 150,000 patients worldwide have received Medtronic DBS Therapy.

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WHAT IS A HUMANITARIAN USE DEVICE?

The Food and Drug Administration (FDA) approved Medtronic DBS Therapy in 2009 as a Humanitarian Use Device for OCD. A Humanitarian Use Device is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 7,000 new people in the United States each year.

The FDA reviewed the safety of Medtronic DBS Therapy for OCD and determined that the probable health benefits outweigh the risks of injury or illness from its use. Efficacy of treatment (effectiveness) has not been established by large clinical trials. Surgery to implant the system can only be performed in a medical center whose institutional review board has approved use of the device.

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WHAT IS THE COST OF MEDTRONIC DBS THERAPY FOR OCD?

The total cost varies significantly. Please contact your healthcare provider for an estimate of the costs associated with DBS Therapy.

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WILL MY INSURANCE COVER DBS?

Coverage for Reclaim™ DBS Therapy is typically made on a case-by-case basis by Medicare, Medicaid, and private payers. Humanitarian Use Devices are eligible for Medicare coverage if the treatment is provided by a site that has institutional review board approval. Please contact your insurance company to see if your health plan provides coverage.

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