FREQUENTLY ASKED QUESTIONS DBS THERAPY FOR DYSTONIA

QUESTIONS ABOUT DBS THERAPY FOR DYSTONIA

If you don’t see your questions answered here, write them down to ask your doctor.


WHAT ARE THE IMPLANTED COMPONENTS OF THE MEDTRONIC DBS SYSTEM?

One or two neurostimulators are needed for dystonia* therapy. The implanted components are:

  • One or two wires (leads) implanted in the brain
  • One or two extensions. Your surgeon will connect the leads to the neurostimulator using extensions that run under the skin from the chest to your neck and head
  • One or two neurostimulators, usually implanted beneath the skin in the chest below the collarbone and connected to the extension (depending on the patient, a surgeon may implant the neurostimulator in the abdomen)

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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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IS IT POSSIBLE TO ADJUST THE DEVICE SETTINGS?

The device settings and stimulation levels can be adjusted noninvasively by a clinician using a programming device.

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

Consult your doctor before any medical treatment or diagnostic test (for example, MRI, mammograms, electrocautery, or heart defibrillation). You should not have diathermy (deep heat treatment) under any circumstances.

See MRI information about deep brain stimulation for dystonia.

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DOES THE MEDTRONIC DBS SYSTEM MAKE ANY NOISE?

No.

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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 2003 as a Humanitarian Use Device for dystonia. A Humanitarian Use Device is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 8,000 new people in the United States each year.

The FDA reviewed the safety of Medtronic DBS Therapy for dystonia 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 DYSTONIA?

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 THERAPY?

Coverage for DBS is typically on a case-by-case basis for Medicare and private payers. Humanitarian Device Exemption (HDE) products 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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Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

*

Humanitarian Device - Authorized by Federal Law as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis), in patients seven years of age or above. The effectiveness of the devices for treating these conditions has not been demonstrated.