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Medtronic data on file: Report; NDHF1443-128376 - DBS Expanded MRI Labeling RF Lead Heating Design Verification Test Report
Medtronic’s Activa™ PC+S device received CE Mark on January 17, 2013, but was not commercially distributed.
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 +44 (0) 1923 205101 for a complete list of conditions. Also review current MRI manufacturer labeling before conducting the MRI.
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan® device, see the MRI SureScan® technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.