Report Fingers 2nd St. Jude Device For In-Body Wire Failure

Law360, New York (June 13, 2012, 6:27 PM EDT) -- St. Jude Medical Inc. is examining a physician's report to the U.S. Food and Drug Administration that the company's heart-device wiring broke though insulation inside a patient's body, the same issue that forced it to recall a predecessor device, the company said Wednesday.

According to a recent report in the FDA's MAUDE database, a physician performing a fluoroscopy discovered that a patient's Durata defibrillator lead had poked through protective insulation, or externalized. Leads are wires that attach heart tissue to the defibrillator.

The filing has garnered...
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