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A U.S. Food and Drug Administration analysis found that Guidant defibrillators may fail as much as 10 times more than the company projected last year.
Guidant defibrillators have been implanted into thousands of cardiac patients and are used to restart hearts with electrical pulses. The company recalled 16,000 of its Contak Renewal defibrillators last year but said that no more than 292 of the units were likely to experience problems.
The findings of the confidential FDA analysis were unsealed in a Texas product liability lawsuit against Guidant Corp. The document, dated June 16, 2005, said that thousands of the company''s implantable heart devices may experience malfunctions within five years.
The FDA report said that “most” of the recalled defibrillators may have damaged insulation within that time – 40 percent of which would fail to produce a life-saving shock in a medical emergency.
“This is as damaging a document as we''re going to come across,” said Hunter Shkolnik, one of a number of attorneys who are representing patients with the faulty devices.
Recently unsealed documents show that Guidant wrote a letter to doctors warning of the risk of dangerous electrical malfunction with its defibrillators, but never sent the letter.