Safety Notice for EnRhythm, EnRhythm MRI and Advisa pacemakers, Medtronic
2010.02.18
Product group Active implantable medical devices
Reference 00475/10
Medtronic has issued a field safety corrective action on specific pacemaker models “EnRhythm” (model P1501DR), “EnRhythm MRI” (model EMDR01) and “Advisa” (subset of clinical devices, model A5DR01). Higher than expected battery resistances may result in wrong display of battery voltages during telemetry of such devices.