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The FDA initially recommended that patients leverage remote monitoring processes, including manual patient-initiated transmissions every three months and utilizing Merlin.net, which provides pacemaker-initiated alerts within 24 hours of a device reaching Elective Replacement Indicator and End of Service statuses.
However, evidence from the case report suggests that these remote monitoring precautions were not completely successful in detecting battery depletion in the pacemakers.
“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,” Michael J. Cutler, DO, PhD, author of the case report and a physician at Intermountain Heart Institute, said in a press release.
“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.”
The two patients included in the case study experienced a loss of pacing due to complete battery depletion in their CRM devices. As a result, the patients urgently needed to replace their pacemakers.
Although the FDA and Abbott advised patients to use a remote monitoring site to track their device’s battery life, there was no communication between the pacemaker and the Merlin.net tool due to the sudden battery failure. Because the remote monitoring strategy of generating alerts was not successful, the patients’ physicians were not notified.
The case studies highlighted the fact that remote monitoring may not have the capability to detect if a pacemaker loses its pacing functions.
According to Cutler, these particular case studies were published to help make other physicians aware of this possible flaw in the St. Jude Assurity and Endurity pacemakers. Physicians who have implanted these devices in patients should monitor them closely and change the pacemaker if necessary.
Cutler and his team are continuing to monitor patients on a case-by-case basis to determine the consequences of a loss of pacing and if the patients require a pacemaker change.
“The process of developing this course of action highlights the opportunity for improved collaboration between industry, health systems, medical societies, and individual healthcare providers in the management of CRM device performance deficiencies,” Cutler said.
Additionally, Abbott developed a software patch to address the pacemaker manufacturing flaws. The software patch allows for closer monitoring of the pacemaker battery life and may be able to identify premature battery depletion, according to the lead author of the case report Yonathan F. Melman, MD, PhD, of the Intermountain Heart Institute. The software patch may also work as an alternative to changing patients’ pacemakers.
Although some remote patient monitoring tools may aid in tracking certain cardiac conditions, the Abbott pacemaker case studies revealed that remote monitoring experienced lags when trying to detect device battery failure.
