Brief Statement: Medtronic DBS Therapy for Epilepsy

Patients should always discuss the potential risks and benefits with a physician.

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.

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 or worsen. Medtronic DBS Therapy may cause new or worsening neurological or psychiatric symptoms. 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 Epilepsy, 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.

Rev 02/22