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Benefits and Risks – DBS Therapy

Essential Tremor

DBS Therapy may help control symptoms of essential tremor. Here you can find out about the benefits of DBS Therapy and safety considerations. Then you will be prepared for a conversation with your doctor about whether DBS Therapy may be right for you.

DEMONSTRATED Effective

Clinical studies have shown that Medtronic DBS Therapy for Tremor provides:1

  • Less tremor
  • Improved ability to do everyday activities

Hand and Arm Tremor

DBS Therapy is FDA-approved to treat one “upper extremity,” which means one arm and hand. Usually the hand used most often is treated. DBS Therapy may help symptoms of essential tremor that happen with or without trying to move.

Established Therapy

Medtronic DBS Therapy for Tremor Control was approved by the US Food and Drug Administration in 1997. So far, more than 135,000 people have had Medtronic DBS Therapy for essential tremor and other disorders.

Programmed for Your Needs

Your doctor will program the device to best control your individual symptoms. Programming is done wirelessly. The system can also be turned off if necessary. You may have a controller that will allow you to turn the system on and off, adjust the stimulation, and check the battery.

ACCESS TO MRI

Medtronic provides the first safe* access to MRI anywhere on the body with some DBS systems under certain conditions — giving your doctor an important tool for diagnosis. Approximately 7 out of 10 DBS-eligible patients with movement disorders may need an MRI within 10 years of receiving their device.2 We know it's important that you have safe access to MRI. That's why we performed rigorous testing of Medtronic DBS systems.

Some Medtronic DBS devices may remain on — when programmed to certain settings — throughout the MRI so your DBS therapy is not interrupted.  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 Don’t Need to Wait

If your symptoms are difficult, see a specialist and find out if DBS Therapy is right for you.

Keeps Your Future Options Open

Another important benefit is that DBS Therapy will not reduce your future therapy options. DBS Therapy is reversible, and the system can be turned off or removed. Down the road, you can take advantage of a new treatment or even a cure.

Safety Information and Risks

Placing the DBS system requires brain surgery, which could have serious and even fatal complications including coma, bleeding inside the brain, stroke, seizures, and infection. Once implanted, the system may become infected, parts may wear through your skin, and the lead and/or 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 symptoms to return or worsen. Medtronic DBS Therapy may cause new or worsening neurological symptoms, including motor and speech, and psychiatric disorders. 

In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts, and suicide have been reported.

For complete safety information about Medtronic DBS Therapy, please consult your doctor, call the Medtronic DBS Helpline on +44 (0) 1923 205101, or go to Important Safety Information.


*Medtronic DBS systems are MR Conditional which means they are safe for MRI scans only under certain conditions. If the conditions are not met, the MRI could cause tissue heating especially at the implanted lead(s) in the brain which may result in serious and permanent injury or death. Before having an MRI, always talk with the doctor who manages your DBS Therapy to determine your eligibility and discuss potential benefits and risks of MRI. For further information, please call the Medtronic DBS Helpline on +44 (0) 1923 205101.


References

1

Medtronic DBS Therapy for Parkinson's Disease and Essential Tremor Clinical Summary, 2015.

2

Falowski S, Safriel Y, Ryan M, Hargens L. The need for magnetic resonance (MR) imaging in the United States (US) deep brain stimulation (DBS) population. Presented at: 18th Annual North American Neuromodulation Society Conference; December 11-14, 2014; Las Vegas, NV. Erratum: FDA first approved MR Conditional instructions for use (head scans only) for Medtronic DBS Therapy 14 years ago (approved January 14, 2002).


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.