Implanting physicians and practices that manage patients with these devices should be aware of this possible failure mode. Cutler explained that the cases were submitted for publication “to inform and alert physicians treating affected patients of the possibility of an abrupt loss-of-pacing failure, with potentially life-threatening implications. Continued surveillance and FDA reporting of relevant adverse events are essential for these devices to establish the incidence and frequency of these events and guide recommendations in the future.ĭr.

Many more pacemakers involved in the recall may have already or will abruptly lose their ability to pace. C: The available pacemaker diagnostics highlighting the abrupt battery failure occurring between July 1 and July 10 with lack of capture of the battery failure from July 1 to July 10 by remote monitoring (Credit: Heart Rhythm Case Reports).īecause these two cases occurred around the same time and in close geographic proximity, it raises the possibility that there are significantly more cases than initially suspected, and that Abbott’s estimate of a 0.01% failure rate for 335,000 potentially affected active devices worldwide represents only a fraction of actual cases. B: The presentation electrocardiogram of the patient in case 2 with pacemaker failure demonstrating sinus rhythm with first-degree atrioventricular (AV) block, sinus pauses, and intermittent second-degree AV block with failure to sense and pace the pacemaker. Loss of transmitting capability from a pacemaker may not be immediately detected and the resulting loss of all pacing functions may go undetected by remote monitoring.Ī: Baseline electrocardiogram of the patient in case 2 demonstrating sinus rhythm with right ventricular pacing.

Flawed preparation of the epoxy used in manufacturing allowed moisture to seep into some devices and cause premature battery depletion and loss of pacing without forewarning. In both cases there was no communication between the pacemaker generator and the Merlin communicator because of abrupt battery failure that subsequently caused a loss of pacing as a result, no alert was sent to their physicians. The two patients presented in the case study experienced unexpected and complete loss of pacing via their CRM devices due to complete battery depletion, resulting in symptoms requiring urgent device replacement. The FDA subsequently upgraded its advisory to a Class I recall of a larger cohort of these pacemakers, with recommendations for closer remote monitoring of implanted devices – advice that the evidence suggests might not detect all failures. Jude Assurity and Endurity pacemakers on March 15, 2021, with an initial recommendation for remote monitoring through, which provides an automated alert within 24 hours of a device reaching Elective Replacement Indicator and End of Service. The FDA issued a safety notice about a subset of St. “As such, current manufacturer recommendations for reliance on remote monitoring for early detection of premature battery depletion are likely not sufficient for pacemaker-dependent patients. Cutler, DO, PhD, Intermountain Heart Institute, Murray, Utah, USA. “The cases we present highlight the limitations of remote monitoring for the early identification of CRM device battery failure, particularly in cases in which sudden complete battery failure is possible,” said author Michael J.

The initial recommendations were to ensure standard monitoring was in place, which consists of manual patient-initiated transmissions every three months and pacemaker-initiated alerts for certain device-related issues. The case report highlights how the device maker’s recommendations for managing affected patients post recall did not account for this shortcoming or sufficiently address patient safety, even with the FDA’s repeated actions. Jude Assurity and Endurity pacemakers (manufactured by Abbott) that shed light on a potentially lethal flaw of remote monitoring. A case report in Heart Rhythm Case Reports, an official journal of the Heart Rhythm Society, published by Elsevier,documents two instances of premature battery failures in a recalled subset of St.

Even after the Food and Drug Administration (FDA) issued a safety notice and recall, manufacturing defects in certain cardiac rhythm management (CRM) devices led to premature battery depletion that was not picked up by remote monitoring.

Failure to sense vs failure to capture