Deep brain stimulation therapies and products For healthcare professionals

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 these uses 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 for a complete list of conditions. Refer to the MRI Guidelines for Medtronic Deep Brain Stimulation Systems at www.medtronic.com/mri or contact Medtronic at 800-328-0810 for a complete list of conditions.

The sensing feature of the Percept™ PC system is intended for use in patients receiving DBS where chronically-recorded bioelectric data may provide useful, objective information regarding patient clinical status.  Signal may not be present or measurable in all patients.  Clinical benefits of brain sensing have not been established.