WASHINGTON, D.C. — Both the U.S. Food and Drug Administration (FDA) and the medical device manufacturer Medtronic knew that the battery and wire connection in a pacemaker made by Medtronic was defective and did nothing for over one year. Medtronic, with the blessing of the FDA, has since issued a product recall for the fault pacemaker after patients began experiencing side effects caused by the defects in the device. The website Cardiovascular Business reported that the Journal of American Medical Association (JAMA) released findings showing that the FDA did not fully comprehend the problem and also said that the information the agency possessed was not complete.
The recall issued by Medtronic for its “InSynclll” model 8042 cardiac resynchronization pacemaker, or CRT-P for short, was recalled in 2015 and was implanted in patients between May of 2003 and January of 2011. The researchers studied how the recall came about and what the FDA knew and what Medtronic knew for a year leading up to the formal recall initiative.
Medtronic announced the recall of 9,300 CRT-P devices because due to film buildup on the battery cathode that causes the battery to decrease output and force the pacemaker to stop working altogether. Medtronic estimated that the risk of death, while existent, was minuscule. The problem was that the patients had no idea this was happening until they needed the pacemaker to intervene during a cardiac event.
Out of the 90 people studied in the JAMA article, one person died, another person went into cardiac arrest, five people experienced cardiac symptoms, and six people were diagnosed with worsening of heart failure problems.
The research suggests that the FDA and Medtronic knew there was a life-threatening problem over a year-and-a-half before the recall campaign started. The delay left most people in the dark. The researchers suggest that the FDA needs to improve its reporting system that favors patient safety over manufacturer convenience or profit.
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