BRIEF STATEMENT: MEDTRONIC DBS THERAPY FOR DYSTONIA
Patients should always discuss the potential risks and benefits with a physician.
Medtronic DBS Therapy for Dystonia*: Medtronic DBS Therapy for Dystonia is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) 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.
Placing the DBS system requires brain surgery, which can have serious and sometimes fatal complications including bleeding inside the brain, stroke, seizures, and infection. Once implanted, infection may occur, 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, worsen or become life-threatening, as with status dystonicus, which requires immediate medical treatment. Medtronic DBS Therapy may cause new or worsening neurological or psychiatric symptoms.
In patients receiving Medtronic DBS Therapy for Dystonia, depression, suicidal thoughts, and suicide have been reported, although no direct cause-and-effect relationship has been established.
This therapy is not for everyone. Implantation of a DBS system is contraindicated (not allowed) 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 other sources of electromagnetic interference which may result in serious patient injury or death, system damage or changes to the neurostimulator or to stimulation.
A prescription is required. Not everyone who receives DBS Therapy will receive the same results.
*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.
Rev 02/22