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Greg Webb
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St. Jude Medical—FDA Warning Now Public

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Despite receiving a warning letter from the FDA with regard to its manufacturing and quality control problems at the Sylmar, California, plant which manufactures defibrillators, St. Jude Medical apparently has not yet addressed other problems in its manufacture related to the Durata lead, which connects the defibrillator to a patient’s heart. Now that the contents of the warning letter have been released, the latest information seems to contradict information learned earlier.

A recent New York Times article stated that it appears “the FDA’s patience with St. Jude was running out.” This, following the disclosure of the contents of the FDA letter, which noted that St. Jude “had not made required reports promptly about possible malfunctions of the Durata lead that might have resulted in deaths or serious injuries.”

Amy Jo Meyer, St. Jude’s spokesperson, indicated that “complaint reports at issue involved defibrillator wires that had not been implanted in patients.” (The New York Times, January 16, 2013) The FDA wants St. Jude to respond within 15 days of the steps it will take to correct the problems identified or St. Jude could face civil penalties as well as “notification of federal health care agencies that purchase St. Jude’s products.” (NYT, 1/16/13)