IMPORTANT SAFETY INFORMATION DBS Therapy for Epilepsy

Brief Statement: Medtronic DBS Therapy for Epilepsy

Medtronic DBS Therapy for Epilepsy: Patients should always discuss the potential risks and benefits with a physician.

INDICATIONS: Bilateral stimulation of the anterior nucleus of the thalamus (ANT) using the Medtronic DBS System for Epilepsy is indicated as an adjunctive therapy for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to 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.

CONTRAINDICATIONS: Medtronic DBS Therapy is contraindicated (not allowed) for patients who are unable to properly operate the neurostimulator. The following procedures are contraindicated for patients with DBS systems: diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy), which can cause neurostimulation system or tissue damage and can result in severe injury or death; Transcranial Magnetic Stimulation (TMS); and certain MRI procedures using a full body transmit radio-frequency (RF) coil, a receive-only head coil, or a head transmit coil that extends over the chest area if the patient has an implanted Soletra™ Model 7426 Neurostimulator, Kinetra™ Model 7428 Neurostimulator, Activa™ SC Model 37602 Neurostimulator, or Model 64001 or 64002 pocket adaptor.

WARNINGS: There is a potential risk of brain tissue damage using stimulation parameter settings of high amplitudes and wide pulse widths. Extreme care should be used with lead implantation in patients with a heightened risk of intracranial hemorrhage. Sources of electromagnetic interference (EMI) may cause device damage or patient injury. Theft detectors and security screening devices may cause stimulation to switch ON or OFF and may cause some patients to experience a momentary increase in perceived stimulation. The DBS System may be affected by or adversely affect medical equipment such as cardiac pacemakers or therapies, cardioverter/defibrillators, external defibrillators, ultrasonic equipment, electrocautery, or radiation therapy. MRI conditions that may cause excessive heating at the lead electrodes which can result in serious and permanent injury including coma, paralysis, or death, or that may cause device damage, include: neurostimulator implant location other than pectoral and abdominal regions; unapproved MRI parameters; partial system explants (“abandoned systems”); misidentification of neurostimulator model numbers; and broken conductor wires (in the lead, extension or pocket adaptor). The safety of electroconvulsive therapy (ECT) in patients receiving DBS Therapy has not been established. 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. Depression, suicidal ideations and suicide have been reported in patients receiving Medtronic DBS Therapy for Epilepsy, although no direct cause-and-effect relationship has been established. Preoperatively, assess patients for depression and carefully balance this risk with the potential clinical benefit. Postoperatively, monitor patients closely for new or changing symptoms of depression and manage these symptoms appropriately. Patients should be monitored for memory impairment. Memory impairment has been reported in patients receiving Medtronic DBS Therapy for Epilepsy, although no direct cause-and-effect relationship has been established. The consequences of failing to monitor patients are unknown. When stimulation is adjusted, monitor patients for new or increased seizures, tingling sensation, change in mood, or confusion. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement that may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. Patients should avoid manipulating the implanted system components or burr hole site as this can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Patients should not dive below 10 meters (33 feet) of water or enter hyperbaric chambers above 2.0 atmospheres absolute (ATA) as this could damage the neurostimulation system, before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their clinician.

PRECAUTIONS: Loss of coordination in activities such as swimming may occur.

ADVERSE EVENTS: Adverse events related to the therapy, device, or procedure can include intracranial hemorrhage, cerebral infarction, CSF leak, pneumocephalus, seizures, surgical site complications (including pain, infection, dehiscence, erosion, seroma, and hematoma), meningitis, encephalitis, brain abscess, cerebral edema, aseptic cyst formation, device complications (including lead fracture and device migration) that may require revision or explant, extension fibrosis (tightening or bowstringing), new or exacerbation of neurological symptoms (including vision disorders, speech and swallowing disorders, motor coordination and balance disorders, sensory disturbances, cognitive impairment, and sleep disorders), psychiatric and behavioral disorders (including psychosis and abnormal thinking), cough, shocking or jolting sensation, ineffective therapy and weight gain or loss.

The safety and effectiveness of this therapy has not been established for patients without partial-onset seizures, patients who are pregnant or nursing, patients under the age of 18 years, patients with coagulopathies, and patients older than 65 years.


USA Rx Only Rev 03/20