Medical device monitoring challenges

Improved collaboration between industry, health systems, medical societies and individual healthcare providers is needed to effectively manage implanted medical device recalls, according to an article published in Heart Rhythm Case Reports.

The journal, published by Elsevier, has documented two instances of premature battery failures in a recalled subset of St. Jude Assurity and Endurity pacemakers (manufactured by Abbott) that shed light on a potentially lethal flaw of remote monitoring.

“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 Cutler, DO, PhD, Intermountain Heart Institute, Murray, Utah, USA.

“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.”

Dr 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. Implanting physicians and practices that manage patients with these devices should be aware of this possible failure mode. Consideration should be given to close monitoring or to prophylactic generator change in appropriate patients.”

He further noted that his team has elected the latter option, evaluating patients with recalled devices on a case-by-case basis to consider changing out the pacemaker in patients for whom a loss-of-pacing failure may be life threatening. “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.”

Furthermore, since the initial patient cases were reported to Abbott, the manufacturer has developed a software patch called “EPI”, which allows closer monitoring of battery life for the devices affected by this recall. This software may obviate the need for prophylactic generator changes in many patients.

“The software patch is an important tool in monitoring our patients and may be able to pick up most cases of premature battery depletion. We suggest physicians discuss the role of using the software as an alternative to generator changeout in appropriate patients. Abbott developed the software in response to our concerns, and this reflects the importance of the role of treating physicians in working with industry to ensure that our patients get optimal care,” added lead author of the paper Yonathan F Melman, MD, PhD, McKay Dee Medical Center, Intermountain Heart Institute, Ogden, UT, USA.

Writing in an accompanying editorial, Mikhael F El-Chami, MD, Professor of Medicine, Emory University School of Medicine, Atlanta, GA, USA, commented that the authors of this case report should be commended for reporting these two cases.

“When it comes to identifying problems with cardiac implantable electronic devices, the onus is not only on the device manufacturer and the FDA but also on the physicians. The latter are on the forefront and are often the first to encounter problems with these devices. Reporting these potential malfunctions will help regulatory agencies and device manufacturers identify whether these issues fall within the expected range of a malfunction or exceed it. Therefore, complacency should have no role when it comes to identifying and reporting unexpected device malfunctions.”

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