Report Raises Concerns Over St. Jude Medical Heart Device

Published: Nov 21, 2012

A report on an inspection of a St. Jude Medical facility released Tuesday by federal officials found significant flaws in the company’s testing and oversight of a controversial heart device component, a copy of the document shows. The report may also raise questions about how St. Jude executives recently depicted the inspection’s contents to investors and others. The report by the Food and Drug Administration centered on the company’s handling of a product known as the Durata, a critical electrical wire that connects an implanted defibrillator to a patient’s heart. St. Jude uses a material called Optim to insulate the component and preserve its electrical integrity. But questions about the durability of Optim have arisen following the failure of another St. Jude lead that uses an earlier material and has since been recalled. In October, St. Jude filed a version of the inspection report with the Securities and Exchange Commission but blacked out several portions of the report that referred to the Durata. At the time, the company said it was redacting the report based on what it said was its "good faith interpretation" of how the F.D.A. would act when releasing the document in response to a Freedom of Information Act request.

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