St. Jude’s Durata Linked to Case of Externalized Wire
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St. Jude Medical Inc.’s Durata, a wire used to connect life-saving defibrillators to the heart, was linked to a rare and dangerous fraying defect in one patient in a report to U.S. regulators.
A doctor voluntarily reported the case of a so-called externalized wire from April 17 to the Food and Drug Administration, according to a posting on the agency’s Maude safety database. The unidentified doctor didn’t tell St. Paul, Minnesota-based St. Jude, according to the FDA’s posting.