A defibrillator model manufactured by a well-known medical device company might be dangerous for its users, a report filed in June with the U.S. Food and Drug Administration suggested.

The report (which has not yet been corroborated) claimed that in St. Jude Medical’s Durata-model defibrillator, the cord connecting the device to the user’s heart can break through its insulation. The claim drew notice in the medical-device industry (and caused St. Jude’s stock price to fall) because the alleged defect is similar to one in an older St. Jude defibrillator model, Riata—a defect that ultimately prompted the company recall the devices. Studies of Riata defibrillators had found that as much as 30 percent of the devices had the defect, and one report linked at least 20 deaths to the problem. St. Jude pulled the defibrillators from the market in 2010.

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