13,440 pacemakers recalled due to software error (February 2019)(fda.gov)
fda.gov
13,440 pacemakers recalled due to software error (February 2019)
https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-inc-recalls-dual-chamber-implantable-pulse-generators-ipgs-due-possible-circuit-error
"For this error to occur, a unique combination of events must take place while the device is processing an atrial-sensed event. If this error occurs, the device will be unable to provide pacing until a ventricular-sensed event (VS) is detected. Once a VS is detected, normal pacing functionality is restored immediately. If a VS is not detected, the device will withhold both atrial and ventricular pacing. In addition, until a VS is detected, the device will be unable to initiate a session with a programmer, initiate a session with a CareLink™ remote monitor, or respond to a magnet. "