MRI with Medtronic Deep Brain Stimulation Systems
Now, it is safe* for eligible Medtronic DBS Therapy patients to have a MRI scan anywhere on the body under certain conditions.
Full-Body MR Conditional Systems
MR Conditional deep brain stimulation systems within the Medtronic Activa® portfolio have received FDA approval for full-body magnetic resonance imaging (MRI). Patients receiving a new system and currently implanted patients may be eligible under certain conditions.
- Activa PC Model 37601 neurostimulator
- Activa RC Model 37612 neurostimulator
- Activa SC Model 37603 neurostimulator
Activa SC Model 37602 is not eligible for full body MRI.
Applicable systems include both currently implanted systems and new implants.
The applicable systems may:
- give you options for the diagnostic imaging tests you can order anywhere on the body for falls or comorbidities in your deep brain stimulation patients.
- make your patient more comfortable during the scan because the device can remain on with certain settings (bipolar mode), which may control symptoms.
- enhance MRI image quality because of reduced patient movement.
- increase radiofrequency (RF) power compared to Medtronic head-only limits, allowing enhanced image quality, faster scan times, or larger scan coverage for improved diagnostic capabilities.
Head-Only MR Conditional Systems
Other Medtronic DBS systems continue to be approved only for MRI scans of the head,under certain conditions.
- Soletra® Model 7426 neurostimulator
- Kinetra® Model 7428 neurostimulator
- Activa SC Model 37602 neurostimulator
- Model 64001 and Model 64002 pocket adaptors implanted with any DBS system
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.
Conduct MRI examinations only according to the MRI Guidelines for Medtronic Deep Brain Stimulation Systems.
Failure to follow all warnings and guidelines related to MRI can result in serious and permanent injury including coma, paralysis, and death.