Merlin Patient Care System - Programmer Software

Abbott is notifying physicians of a programmer software anomaly that may be encountered in a very specific circumstance when executing a pacing capture decrement test in-clinic on a gallant, neutrino NXT, or entrant device using a merlin patient care system (PCS) programmer. If a user presses the "hold to test" button and decides to stop testing by releasing the button prior to the first voltage decrement (within a narrow time window approximately 2.5 seconds after test initiation), the programmer may continue to execute the decrement test instead of terminating the test and restoring the permanent programmed pacing parameters. Under this scenario, the decrement test will continue running until an output of 0.25V is reached or until telemetry communication is broken. For pacemaker dependent patients, there is a potential for this scenario to cause a transient asystole until permanent parameters are restored if the voltage is below the patient's capture threshold.

Recall start date: Mar 15, 2022