This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Medtronic DBS System for Epilepsy
PMA Applicant: Medtronic, Inc.
Address: 7000 Central Avenue, N.E., Minneapolis, MN 55432
Approval Date: April 27, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf/P960009S219a.pdf
What is it? The Medtronic Deep Brain Stimulation (DBS) System for Epilepsy is a device that delivers controlled electrical pulses to a location inside the brain which is involved in seizures. The system consists of a pulse generator (IPG) implanted under the skin of the upper chest, and two leads implanted in the brain. The Medtronic DBS System for Epilepsy helps reduce the frequency of seizures in epilepsy patients who have frequent, disabling, partial-onset seizures and have not responded well to antiepileptic medications.
How does it work? A pulse generator implanted under the skin of the upper chest sends a constant stream of tiny electrical pulses through the leads (wires) to the electrodes in selected area of the brain. The electrical impulses block the seizures associated with epilepsy.
When is it used? The Medtronic DBS System for Epilepsy is used in conjunction with antiepileptic drugs in individuals 18 years of age or older with partial onset seizures, with or without secondary generalization, who have not responded to three or more antiepileptic medications. The Medtronic DBS System for Epilepsy is used in patients who average six or more seizures per month. It has not been evaluated in patients with less frequent seizures.
What will it accomplish? The Medtronic DBS System for Epilepsy is intended to reduce the frequency of seizures. The clinical study demonstrated that patients with the device turned on experienced a 17 percent greater reduction in the average number of seizures per month as compared to the percent reduction in patients who had the device turned off.
When should it not be used? Patients with the Medtronic DBS System for Epilepsy cannot have the following procedures:
- Magnetic Resonance Imaging (MRI)
- Transcranial Magnetic Stimulation (TMS)
- Diathermy procedures
The energy created from these procedures can be sent through the stimulator and can cause permanent brain damage, even if the device is turned off.
The Medtronic DBS System for Epilepsy cannot be used in patients who are unable to operate the device, or who don't have a caregiver who can assist them with operating the device.
Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.