Device:  St. Jude Medical ICDs and CRT-Ds programmed with Merlin Programmer Software Version 17.2.2 rev. 0 Inappropriate Programmer Setting of Return to Sinus Detection Criteria in SJM ICDs and CRT-Ds Programmed to a Single VF Detection Zone

Advisory Grade: Hazard Alert (Implanted Devices)

ANZCDACC Advisory Grade: Elective/Routine

Number at Risk: Unknown currently depends on device programming

Description: A software anomaly has been discovered in the above devices if programmed to a single VF zone whereby the event is ended inappropriately and returns to commencement defibrillation therapies and does not proceed to the next tier of defibrillation therapies. If a device is programmed with a low initial shock output and this fails it will return to this level of therapy and not proceed to higher (maximum) output defibrillation therapies.

There is a software upgrade available to fix it. Patients programmed to a single VF zone with the above software should present immediately for the upgrade.