Important Safety Information
Brief Statement: Medtronic DBS Therapy for Parkinson’s Disease, Tremor, Dystonia, Obsessive-Compulsive Disorder, and Epilepsy
Patients should always discuss the potential risks and benefits with a physician.
Medtronic DBS Therapy for Parkinson’s Disease : Deep brain stimulation (DBS) helps control the movement symptoms of Parkinson’s disease, including tremor, slowed movement, and stiffness. You may be a candidate for this therapy if you have had levodopa-responsive Parkinson’s for at least 4 years and at least 4 months of movement symptoms not well controlled by medications or medication side effect such as unintended movements (dyskinesia).
Medtronic DBS Therapy for Tremor : Deep brain stimulation (DBS) delivers electrical stimulation to an area in the brain to help treat essential tremor. Electrical stimulation is only delivered to one side of the body and is used to treat tremor in one arm of the body. You may be a candidate for this therapy if you have essential tremor not adequately controlled by medications and the tremor is disabling.
Medtronic DBS Therapy for Dystonia : Deep brain stimulation (DBS) Therapy for Dystonia is indicated for bilateral stimulation of the internal globus pallidus (GPi) as an aid in the management of chronic, intractable (oral and/or injectable medication refractory) primary dystonia, including:
generalized dystonia, segmental dystonia of the head and neck, and cervical dystonia (torticollis) in adult patients.
generalized dystonia in pediatric patients twelve years of age or above.
Medtronic Reclaim™ DBS Therapy for Obsessive-Compulsive Disorder* : The Medtronic Reclaim™ DBS Therapy is indicated for bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).
Medtronic DBS Therapy for Epilepsy : Deep Brain Stimulation (DBS) Therapy for Epilepsy is an adjunctive therapy (used along with medications) that delivers electrical stimulation to an area in your brain to reduce the frequency of seizures. You may be a candidate for this therapy if you are 18 years of age or older and diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are not adequately controlled by three or more antiepileptic medications. The Medtronic DBS System for Epilepsy has demonstrated safety and effectiveness for patients who average six or more seizures per month over the three most recent months prior to implant of the DBS system (with no more than 30 days between seizures). The Medtronic DBS System for Epilepsy has not been evaluated in patients with less frequent seizures.
Warning for Obsessive-Compulsive Disorder : Electroconvulsive Therapy (ECT) – The safety of ECT in patients who have an implanted deep brain stimulation (DBS) system has not been established. Induced electrical currents may interfere with the intended stimulation or damage the neurostimulation system components resulting in loss of therapeutic effect, clinically significant undesirable stimulation effects, additional surgery for system explantation and replacement, or neurological injury.
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. Pediatric patients may have increased risk of infections, device-related complications, revisions, and explants compared to adults. Medtronic DBS Therapy may cause new or worsening neurological or psychiatric symptoms. For Epilepsy: cessation, reduction, or initiation of stimulation may potentially lead to an increase in seizure frequency, severity, and new types of seizures. Symptoms may return with an intensity greater than was experienced prior to system implant, including the potential for status epilepticus. Memory impairment has been reported, although no direct cause-and-effect relationship has been established.
In patients receiving Medtronic DBS Therapy for Parkinson’s disease or essential tremor, new onset or worsening depression, suicidal thoughts, suicide attempts, and suicide have been reported. In patients receiving Medtronic DBS Therapy for Dystonia or Epilepsy, depression, suicidal thoughts, and suicide have been reported although no direct cause-and-effect relationship has been established. In patients receiving Medtronic DBS Therapy for Obsessive-Compulsive Disorder, depression, suicidal thoughts, and suicide have been reported.
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. The impact of DBS on overall brain development and behavioral changes in pediatric patients is unknown.
A prescription is required. Not everyone who receives DBS Therapy will receive the same results.
*Humanitarian Device: Authorized by Federal law for use as an adjunct to medications and as alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). The effectiveness of the devices for this use has not been demonstrated.
Rev 12/25
