BRIEF STATEMENT: USE OF MRI DEEP BRAIN STIMULATION

Brief Statement: Use of Magnetic Resonance Imaging (MRI) in Patients with Medtronic DBS Systems

Medtronic DBS systems are MR Conditional which means they are marked to indicate they are safe in the MR environment as long as certain conditions are met. Read and fully understand the MRI Guidelines for Medtronic deep brain stimulation systems before conducting the MRI examination. Always obtain the latest MRI guidelines at www.medtronic.com/mri or contact Medtronic at (1-800)-328-0810 for a copy. Also review current MRI manufacturer labeling before conducting the MRI.

INDICATIONS

Medtronic DBS Therapy for Parkinson’s Disease:
Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms in individuals with levodopa-responsive Parkinson's disease of at least 4 years’ duration that are not adequately controlled with medication, including motor complications of recent onset (from 4 months to 3 years) or motor complications of longer-standing duration.

Medtronic DBS Therapy for Tremor:
Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity.  The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.

Medtronic DBS Therapy for Dystonia^*:
Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Dystonia is indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis), in patients seven years of age or above.

Medtronic Reclaim™ DBS Therapy for Obsessive-Compulsive Disorder^*:
Bilateral stimulation of the anterior limb of the internal capsule, AIC, using Medtronic Reclaim™ DBS Therapy is indicated 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:
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/WARNINGS/PRECAUTIONS

Use of a full body transmit radio-frequency (RF) coil, a receive-only head coil, or a head transmit coil that extends over the chest area is contraindicated for patients with the following implanted DBS systems or system components: Soletra™ Model 7426 Neurostimulator; Kinetra™ Model 7428 Neurostimulator; Activa™ SC Model 37602 Neurostimulator; and Model 64001 and Model 64002 pocket adaptors. Tissue lesions from component heating, especially at the lead electrodes, resulting in serious and permanent injury including coma, paralysis, or death, can occur if a contraindicated MRI scan is performed on a patient with these DBS systems. Other conditions that may cause excessive heating at the lead electrodes which can result in serious injury 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).  Active scan time >30 minutes within a 90 minute window, elevated core body temperature due to fever or use of blankets, or patient position within the MRI bore other than prone or supine, may cause excessive tissue heating.  Leaving therapy on during the scan could increase the potential for uncomfortable, unintended stimulation. Failure to cap a lead-only system may result in unintended stimulation during the scan.  External control devices such as the patient programmer, recharger, external neurostimulator and clinician programmer, are MR Unsafe and not allowed in the MRI scanner (magnet) room.  

HUMANITARIAN DEVICE

The effectiveness of these devices for the treatment of dystonia and obsessive-compulsive disorder has not been demonstrated.

USA Rx only
Rev 08/18