Urgent Safety Notice for Consulta® CRT-P and Syncra® CRT-P devices, Medtronic
2013.06.18
Product group Active implantable medical devices - cardiac pacemakers
Reference 03240/13
Medtronic has issued an urgent field safety notice on pacemakers (Models Consulta® CRT-P and Syncra® CRT-P). Such pacemaker devices may have an out-of-specification weld, which could result in a loss of device hermeticity and compromised device functionality.