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St. Jude Warned by Federal Regulators Over Durata Heart Lead

Filed January 16th, 2013 admin

The U.S. Food and Drug Administration (FDA) has sent a warning letter to St. Jude Medical over issues with the way in which it manufactures items, specifically a Durata cardiac lead, at a facility in Southern California.

Until St. Jude fixes the issues brought forth in the FDA letter, the agency will not approve certain types of cardiac rhythm management products from the company, the StarTribune said. The plant in question is in Sylmar, California, where St. Jude manufactures the Durata defibrillator lead—a wire that connects the defibrillator to the heart. The Durata lead has been the center of controversy over its overall safety.

In November, when it was discovered that the FDA had heightened concerns over processes with Durata, St. Jude’s share price fell nearly 13 percent, the StarTribune said. Durata has been St. Jude’s top defibrillator lead since the company pulled its Riata leads off the market in late 2010, amid safety concerns that were raised when inner wires were discovered to have worked their way through the lead’s insulation.

FDA inspectors visited the facility from September 25 to October 17, 2012, the StarTribune said. The inspection raised multiple concerns with the agency, leading it to file a Form 483 detailing alleged violations at the facility. The Form 483 detailed concerns over issues such as the number of tests performed on Durata leads and the facility’s record-keeping, the StarTribune said.

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