The Food and Drug Administration on Wednesday sent a warning letter to St. Jude Medical, saying the devicemaker downplayed issues with its defibrillator batteries and failed to recall the devices for years, reports The New York Times.
Here are seven things to know.
1. Physicians at Durham, N.C.-based Duke University reported two cases of battery issueswith St. Jude's defibrillators in 2014, and another research team at the University of Illinois in Champaign reported problems in 2015.
2. St. Jude, which Abbott Laboratories acquired in January, addressed the battery defects in 2015 for the new defibrillators it was manufacturing, but did not recall older versions of the device or notify physicians and patients about the battery issues until 2016, according to the report.
3. St. Jude recalled the defibrillators in October 2016, saying the defect did not appear widespread, according to the report. At the time, 841 devices — of the nearly 400,000 sold globally — were returned to St. Jude after their batteries died unexpectedly. The defect caused two patient deaths, along with dozens of other adverse events, according to the FDA. The warning letter says St. Jude knew of one patient death related to the battery defect in 2014, but failed to disclose the information to its management team or medical advisory board, according to the report.
4. While St. Jude claimed the defect was not widespread at the time of the recall, FDA spokeswoman Angela Stark on Thursday said almost 200,000 Americans are implanted with the recalled defibrillator. She said the FDA did not urge St. Jude to recall the devices earlier because the information the devicemaker gave to the agency misrepresented the risk.
5. In the warning letter, the FDA said St. Jude downplayed the issue by identifying reports of the faulty batteries as "unconfirmed," even though the battery manufacturer confirmed the battery defects. The devicemaker also omitted the unconfirmed cases when calculating the malfunction risk to make the issue seem less severe, according to the report.
6. The letter also said St. Jude did not adequately respond to a warning the FDA gave the company in January about cybersecurity vulnerabilities with the devicemaker's defibrillators and remote monitoring system.
7. Abbott told The New York Times it was reviewing the warning letter and is committed to solving the issues the agency brought up regarding St. Jude. "We have a strong history and commitment to product safety and quality," the company said in a statement.
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