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Medtronic’s Activa™ PC+S device received CE Mark on January 17, 2013, but was not commercially distributed.
Medtronic DBS systems are MR Conditional which means they are safe for MRI scans only under certain conditions. If the conditions are not met, the MRI could cause tissue heating, especially at the implanted lead(s) in the brain, which may result in serious and permanent injury or death. Before having an MRI, always talk with the doctor who manages your DBS Therapy to determine your eligibility and discuss potential benefits and risks of MRI. For further information, please call Medtronic at +44 (0) 1923 205101.
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.
For applicable products, consult instructions for use on manuals.medtronic.com. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.