Humanitarian Device: Medtronic DBS Therapy has been authorized by Federal Law for the use as an aid in the management of chronic, intractable (drug refractory} primary dystonia and for people with chronic, severe, treatment-resistant obsessive-compulsive disorder. The effectiveness of this device for theseuses has not been demonstrated.
Medtronic DBS systems are MR Conditional and safe in the MR environment as long as certain conditions are met. If the conditions are not met, a significant risk is tissue lesions from component heating, especially at the lead electrodes, resulting in serious and permanent injury including coma, paralysis, or death. Refer to the MRI Guidelines for Medtronic Deep Brain Stimulation Systems at www.medtronic.com/mri or contact Medtronic at (1-800)-328-0810 for a complete list of conditions. Also review current MRI manufacturer labeling before conducting the MRI.