MRI Important Safety Information for Medtronic SCS Systems
Activa® SC Model 37602/37603
Activa PC Model 37601
Activa RC Model 37612
Kinetra® Model 7428
Soletra® Model 7426
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. For a complete list of conditions and instructions for use, read and fully understand the MRI Guidelines for Medtronic Deep Brain Stimulation Systems and MRI Eligibility Sheet before conducting the MRI examination. Also review current MRI manufacturer labeling before conducting the MRI.
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.
USA Rx only