Safety Notice for Medtronic Ablation Frontiers GENius Multi-Channel RF Generator, Medtronic
2010.12.13
Product group Medical electronics / Electromedical devices
Reference 04400/10
Medtronic informs on a possible interaction when a patient with an implanted cardiac device undergoes an ablation using the Medtronic Ablation Frontiers GENius Multi-Channel RF Generator (Model Number 990018). All current versions of the GENius Multi-Channel RF generator (SW revision 11, 12.2, 14.0, 14.2 and 14.3) are covered by this notification.
This interaction can result in unintended high rate cardiac stimulation on the atrial and/or the ventricular pacing lead, which can induce atrial or ventricular fibrillation.