Merlin™ 3650 Patient Care System (PCS)

Abbott is reaching out to customers to inform about a Merlin™ PCS 3650 programmer software update that addresses a software behavior that may occur during Pacing Capture Threshold (PCT) test of an AVEIR™ Leadless Pacemaker (LP). If intermittent loss of telemetry occurs during PCT test, the programmer may not successfully communicate the command to terminate the test, potentially leaving the LP in sub-threshold pacing until telemetry is fully disconnected. This issue can only occur during a PCT test, which is performed during implant or in clinic follow-up. This issue was identified through a review of complaints data, which confirmed four (4) complaints associated with the issue globally.