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Outcomes Before and After Recall of a Heart Failure Pacemaker
Study Questions:
Is the timing of cardiac device manufacturer recalls and US Food and Drug Administration (FDA) regulation of recalls optimal?
Methods:
Using a case series of patients from the Minneapolis Heart Institute (MHI) affected by a specific pacemaker recall, the authors describe the adverse events, timing of events, and FDA action on the recall. Included patients had the subsequently recalled pacemaker implanted AND were actively observed at MHI at the time of recall release. The recall was issued due to a battery problem that could lead to abrupt cessation of pacing. The FDA classified it as a Class II recall. The FDA MAUDE (Manufacturer and User Facility Device Experience) database was queried to identify all reported battery or output failures from the device.
Results:
Of 448 patients implanted with the device at MHI, 90 were actively observed onward from the first device failure in May 2015. From then until the November 2015 recall, five MHI patients experienced syncope due to pacing failure. MHI electively replaced 18 devices before and 50 after the recall. MAUDE identified 205 device reports: 77% associated with the battery problem and 17% with a second wire problem that was not identified by the recall or FDA. One third of the reported devices had exhibited loss of output. Serious adverse events occurred in 22 patients, including one death. Over 50% of prophylactically replaced devices showed signs of potential failure. The first MAUDE report on the battery problem occurred in April 2014; 22 additional reports were made between then and the recall release. MAUDE reports (n = 15) about the wire problem first appeared in January 2009.
Conclusions:
The authors concluded that the recall was unnecessarily delayed, was not fully revealing of the potential consequences of the failure, and should have been a Class I FDA recall. These oversights resulted in preventable adverse events.
Perspective:
Life-threatening cardiac device failures are an unfortunate reality. Despite high manufacturing integrity, not all device problems are preventable or quickly identifiable. This study frames the problem and conclusion with the illumination of hindsight. Over 96,800 of the devices had been implanted worldwide with 22,000 active at the time of the recall. The 23 battery problem failures by the time of the recall release constituted 0.02% of the total implanted devices. The consequences of prematurely issuing a Class 1 FDA recall would potentially result in thousands of patients undergoing additional procedures with risk. The threshold for the manufacturer and FDA to issue a recall is certain to be an immense challenge and one in which judgment of the optimal timing is relative to foresight and hindsight.
Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure
Keywords: Arrhythmias, Cardiac, Equipment Failure, Equipment Failure Analysis, Heart Failure, Medical Device Recalls, Outcome Assessment, Health Care, Pacemaker, Artificial, Secondary Prevention, Syncope
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