Urgent Safety Notice for Dual Chamber Models of Pacemakers, Medtronic
2011.04.15
Product group Active implantable medical devices
Reference 01512/11
Medtronic has issued an urgent field safety notice on pacemakers (Models Kappa 600, 700, 800, 900, EnPulse, Adapta, Versa, Sensia, Relia and Vitatron models E50A1, E60A1 und G70A1). Such dual chamber pacemaker devices can be affected by a measurement lock-up condition that may inappropriately trigger ERI/RRT.