February 18, 2020
Dr. Jay Sengupta, Minneapolis Heart Institute Foundation® (MHIF) researcher and clinical cardiac electrophysiologist at Minneapolis Heart Institute®, was the principal investigator on a pacemaker recall study published in the February 2020 issue of JAMA Internal Medicine, “Outcomes Before and After the Recall of a Heart Failure Pacemaker.”
The retrospective study examined the experience of 90 patients before and after the 2015 recall of a specific model of cardiac resynchronization therapy pacemaker due to battery and wire connection defects. It sought to determine 1) if the manufacturer’s recommendations following the recall of a medical device were timely and complete, 2) if the follow-up information and data provided to patients and physicians were adequate for managing patient care, and 3) if the actions taken by the US Food and Drug Administration (FDA) regarding the recall were appropriate.
In their conclusions, the authors wrote, “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.”
The Minneapolis Heart Institute Foundation has long established itself as a leader in conducting groundbreaking clinical trials on implantable cardiac devices and their safety, and in a related JAMA podcast interview, Dr. Sengupta explained why MHIF researchers were interested in initiating the study.
“The motivation goes back to following a large number of patients through our very large device clinic,” said Dr. Sengupta. “Back in 2015, we were noticing several individuals who had adverse outcomes from having this pacemaker and that outcome was typically pretty serious. Many of them presented with syncope (a temporary loss of consciousness) and loss of output from the pacemaker. It’s a model of pacemaker that was implanted typically in patients with heart failure and heart block and many patients underwent AV node ablation, so they were often dependent on the pacemaker for heart rate and support. And so when patients had loss of pacing output they could have —and many did have — serious adverse consequences. So when we were reviewing our own data, we found a large number of patients who had this relative to our total population with this device.”
After the manufacturer issued a recall with a safety advisory, it led to the MHIF team’s further interest in reviewing their own experience with patients with the particular pacemaker, and then corroborating that with the returned product reports submitted by the manufacturer to the FDA via the Manufacturer and User Facility Device Experience (MAUDE) database.