
13,440 pacemakers recalled due to software error (February 2019) - s1512783
https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-inc-recalls-dual-chamber-implantable-pulse-generators-ipgs-due-possible-circuit-error
======
s1512783
Medtronic's letter to clinicians contains more details on the issue:
[https://www.medtronic.com/us-en/healthcare-
professionals/pro...](https://www.medtronic.com/us-en/healthcare-
professionals/products/product-performance/dual-chamber-pacemaker-recall.html)

"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. "

