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Important Safety Information

Frequently Asked Questions

Will the device show through my clothes?
Depending on your body build, the neurostimulator may be noticeable as a small bulge under the skin. However, your doctor will try to place the neurostimulator in a place that is most comfortable and cosmetically acceptable.
Is this a permanent procedure?
Medtronic DBS Therapy is a reversible procedure. It is also adjustable, which means that the stimulation can be adjusted to match changes in your symptoms. The system can also be deactivated or even removed. Removal would require additional surgery.
What are the risks associated with this type of treatment?
DBS Therapy requires brain surgery. Risks of brain surgery may include serious complications such as coma, bleeding inside the brain, seizures and infection. Some of these may be fatal. Once implanted, the system may become infected, parts may wear through your skin, and the lead or lead/extension connector may move. Medtronic DBS Therapy could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause your symptoms to return.

Medtronic DBS Therapy may cause worsening of some motor symptoms associated with your movement disorder, and may cause speech and language impairments. Stimulation parameters may be adjusted to minimize side effects and attain maximum symptom control. In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts and suicide have been reported. Occurrence of "fall" has also been reported in patients with Parkinson's disease.

Talk with your doctor about the risks that may be applicable to your specific situation. Details at Important Safety Information.
What does the stimulation feel like?
Most people don't feel the stimulation at all as it reduces their symptoms. However, some people may feel a brief tingling sensation when the stimulation is first turned on. Higher levels of stimulation have been described as uncomfortable, jolting, or shocking. If the stimulation changes or becomes uncomfortable, contact your doctor immediately.
Does the system make any noise?
No.
Will I be able to increase or decrease the strength of stimulation?
In most cases, only your doctor can change the strength of stimulation. Depending on the type of device you have, you may be able to choose from a range of stimulation settings that your doctor has programmed for you.
How long will the device’s battery last?
On average, and depending on programmed settings, an Activa SC neurostimulator battery lasts 4 to 6 years, and an Activa PC neurostimulator battery lasts 3 to 5 years. The rechargeable neurostimulator lasts for 9 years.
What happens when my device is ready to be replaced?
Before your battery runs out, the device will need to be replaced through a surgical procedure.
Can stimulation be used during pregnancy?
The safety and effectiveness of this therapy has not been established for patients who are pregnant.
Is it safe to have medical tests with the system implanted?
Consult your doctor before engaging in any medical treatment or diagnostic test (for example, MRI, mammograms, electrocautery, or heart defibrillation). Diathermy (deep heat treatment) and Transcranial Magnetic Stimulation (TMS) should not be permitted under any circumstances.

Someday, you may need a magnetic resonance image (MRI) head scan to diagnose the cause of a common condition, such as hearing loss, headache, vision problems, seizures, tumors, or stroke. When you have an implanted electronic device, however, you have to be careful about MRI scans. The good news is that all Medtronic DBS systems are designed so that an MRI head scan is possible with proper safeguards. In fact, only Medtronic offers deep brain stimulation systems that are FDA approved for MRI head scans, under specific conditions of use.
Will my insurance cover DBS Therapy?
The current national policy provides coverage for Medicare beneficiaries who qualify as candidates for DBS. (Medicare does not require prior approval before an implant, although you must meet Medicare's criteria in order for the procedure to be covered.) You will still pay deductibles, coinsurance, and copayments.

Typically, your doctor will work with private insurance companies to obtain prior approval. This process normally requires that your doctor send a letter of medical necessity to the insurance company. This letter explains why DBS is appropriate for you. It also describes the other treatments that have been attempted and failed.

It is not uncommon for an insurance company to deny a request for prior approval if they are unfamiliar with the treatment. If you receive a denial and wish to appeal, we're here to guide you and your doctor through this process.