Risks and Probable Benefits Deep Brain Stimulation for Dystonia

Overview

DBS Therapy for dystonia* 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 Since 2003

DBS Therapy has been used for other diseases. So far, more than 140,000 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 in most cases or turned off (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 Medtronic at (800) 328-0810, or go to Important Safety Information.


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.

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 Medtronic at 800-328-0810.