BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Safety Notice for Implantable Cardiac Monitors (Models CONFIRM DM2100 and DM2102), St. Jude Medical

Product group Active implantable medical devices
Reference 01316/11

St. Jude Medical has issued a field safety notice on a limited number of Implantable Cardiac Monitors (Models CONFIRM DM2100 and DM2102) that received a field upgrade of the operational software using the Merlin Programmer Software Version 11.2.2. Such devices may be affected by high current drain state, which can accelerate battery depletion.

Safety Notice for Implantable Cardiac Monitors (Models CONFIRM DM2100 and DM2102), St. Jude Medical , Download_VeroeffentlichtAm_EN PDF, 67KB, File does not meet accessibility standards