Important safety information DBS therapy for essential tremor

BRIEF STATEMENT: MEDTRONIC DBS THERAPY FOR PARKINSON’S DISEASE AND TREMOR

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

INDICATIONS

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.

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.

In patients receiving Medtronic DBS Therapy, new onset or worsening depression, suicidal thoughts, suicide attempts, 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.

A prescription is required. Not everyone who receives DBS Therapy will receive the same results.

Rev 02/22