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Sengupta J, Storey K, Casey S, et al. Outcomes Before and After the Recall of a Heart Failure Pacemaker. JAMA Intern Med. 2020;180(2):198–205. doi:10.1001/jamainternmed.2019.5171
Do the medical device industry and the US Food and Drug Administration (FDA) provide timely information about product defects so that patients and their physicians can make fully informed decisions regarding management?
In this case series, the outcomes of 90 patients before and after the recall of a cardiac resynchronization therapy pacemaker in November 2015 were examined along with review of the FDA Manufacturer and User Facility Device Experience database and showed that the manufacturer and the FDA were aware of battery and wire connection defects for more than 1 year before patients began to develop serious adverse clinical events because of abrupt loss of pacing. The information included in the recall notification was incomplete, and the FDA underestimated the criticality of the pacemaker’s defects.
The medical device industry and the FDA should focus on early recognition of device defects and fully and promptly disclose vital information to patients and their caregivers.
Timely and complete disclosure of medical device defects is necessary to manage patient care safely and effectively.
To determine if the manufacturer’s recommendations following the recall of a medical device were timely and complete, the follow-up information and data provided to patients and physicians were adequate for managing patient care, and the actions taken by the US Food and Drug Administration (FDA) regarding the recall were appropriate.
Design, Setting, and Participants
This single-center retrospective case series included 90 of 448 patients who were implanted with a cardiac resynchronization therapy pacemaker at the Minneapolis Heart Institute from May 2003 through January 2011; this pacemaker was recalled in November 2015. In addition, returned product reports submitted by the manufacturer to the FDA via the Manufacturer and User Facility Device Experience (MAUDE) database from January 2008 through December 2018 were analyzed.
Main Outcomes and Measures
Clinical outcomes were serious adverse clinical events that occurred before and after the November 2015 recall notifying physicians and patients that the device’s battery could fail unexpectedly because of high internal impedance. Technical outcomes were signs and causes of failure.
Five of 90 patients observed during 2015 experienced syncope when their pacemakers stopped pacing owing to battery or wire connection defects prior to the recall. Of the 90 patients, 37 (41%) were men, and the median (interquartile range) age at implantation was 71.3 (66.1-78.2) years. Analysis of the MAUDE data revealed that battery failures prior to the recall were associated with serious adverse events that included 1 death, 1 cardiac arrest, 5 syncopal attacks, and 6 heart failure exacerbations; 3 additional prerecall syncopal events were caused by wire connection defects. The manufacturer and the FDA were aware of the battery and wire connection defects for 19 months before issuing the recall, yet the wire connection problem was not included in the advisory and physicians were not informed that interrogating the pacemaker could result in loss of pacing. The FDA classified the recall as class II rather than the more critical class I.
Conclusions and Relevance
This case series study of patients implanted with a defective pacemaker found that the pacemaker recall was delayed and that subsequent communications did not include all critical information needed for safe and effective patient care. These findings should prompt reforms in how the medical device industry and the FDA manage future medical device recalls.
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