ABOUT THE THERAPY: DYSTONIA DEEP BRAIN STIMULATION
DBS Therapy for dystonia* is approved by the FDA under a humanitarian device exemption for the aid in management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis), in patients 7 years of age or above.
Dystonia can cause severe involuntary muscle contractions that force certain parts of the body into repetitive, twisting movements or painful postures. Although dystonia has no cure, there are a number of treatments available for finding relief. One option for those who are 7 years of age or above with chronic, treatment-resistant primary dystonia may be deep brain stimulation.
Medtronic DBS Therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver carefully controlled electrical stimulation to precisely targeted areas in the brain. Medtronic DBS Therapy is approved for unilateral or bilateral stimulation in patients with dystonia. The implanted system is programmed to customize therapy for the patient.
Medtronic DBS Therapy works by electrically stimulating specific structures that control unwanted symptoms. For dystonia, those structures are the subthalamic nucleus (STN) or globus pallidus interna (GPi).
One or two leads are surgically implanted in the brain and connected to one or two neurostimulators implanted near the collarbone. The neurostimulator contains a small battery and computer chip programmed to send electrical pulses to control symptoms.
A clinician programming device is used to adjust the stimulation to best control the individual’s symptoms while minimizing side effects. Periodic adjustments of the programming are a routine part of therapy.
A patient programming device gives patients some control over their settings, within physician-prescribed limits.
DBS Therapy requires brain surgery. Risks of brain surgery may include serious complications such as coma, bleeding inside the brain, stroke, seizures and infection. Some of these may be fatal. Once implanted, the system may become infected, parts may wear through the 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 symptoms to return or worsen, which may be life-threatening.
Deep brain stimulation may help control some symptoms of dystonia. While DBS may treat some of the symptoms of dystonia, it does not cure the underlying condition. If stimulation is discontinued, symptoms will likely return.
Medtronic gives you the first safe† access to MRI anywhere on the body for diagnosing health conditions in patients with deep brain stimulation. Eligible patients with Medtronic DBS Therapy may have an MRI scan anywhere on the body under certain conditions. Refer to MRI Guidelines for Medtronic Deep Brain Stimulation Systems for a complete list of conditions and instructions for use.
DBS Therapy may be turned off. System components may be removed, in most cases,
preserving options for future therapies and treatments.
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 also cause new or worsening neurological or psychiatric symptoms.
In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts, and suicide have been reported.
This therapy is not for everyone. This therapy should not be used for patients who will be exposed to diathermy (deep heat treatment) or transcranial magnetic stimulation. Magnetic Resonance Imaging (MRI) should only be performed as described in the product labeling. The DBS system may interact with other medical devices and electromagnetic interference.
Healthcare professionals must review the product technical manual prior to use for detailed disclosure. For information refer to Indications, Safety, and Warnings or call Medtronic at 800-328-0810.
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 and safe in the MR environment as long as certain conditions are met. If the conditions are not met, a significant risk is tissue lesions from component heating, especially at the lead electrodes, resulting in serious and permanent injury including coma, paralysis, or death. Refer to the MRI Guidelines for Medtronic Deep Brain Stimulation Systems for a complete list of conditions.