Risks and Probable Benefits – DBS Therapy

DBS Therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver electrical stimulation to precisely targeted areas within the brain.

Probable Benefits

DBS may help control your symptoms, but it is not a cure. When you turn on the DBS system, it will deliver stimulation that may decrease some or all of your symptoms. Your symptoms will return when the system is turned off.

Established Therapy for Over 10 Years

So far, more than 135,000 people have had Medtronic DBS Therapy for movement disorders and other disorders.

Programmed for Your Needs

Your doctor programs the device to best control your individual symptoms. This 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. 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.

Keeps Your Future Options Open

DBS Therapy will not reduce your future therapy options. DBS Therapy is reversible and the system can be removed (unlike other surgical options). Down the road, you can continue medications and take advantage of new treatments, or even a cure.

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 the 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, which may be life-threatening. 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 Helpling on +44 (0) 1923 205101, or go to Important Safety Information.

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