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St. Jude Medical Inc. Message Board

  • Pregu Pregu Apr 7, 2012 8:37 AM Flag

    NYT Article, Troubling Flaws in a Heart Device Shake Implant Makers

    http://www.nytimes.com/2012/04/07/health/flaws-in-st-jude-heart-defibrillator-shake-the-industry.html

    "a high school football coach named Greg Jessee was standing on the sidelines watching his son play when he felt a jolt to his chest. The heart defibrillator implanted in him five years earlier was firing wildly. The next jolt made him double up. The one after that knocked him unconscious... doctors discovered that the cable, or lead, connecting the defibrillator to his heart had failed and that the electrical wires inside it had worked their way out through the lead’s coating... The St. Jude leads at issue involve two models, the Riata and the Riata ST. The company stopped selling both models in late 2010. For the last several years it has been selling a defibrillator lead called the Durata, which it says has an extra coating of insulation that prevents the types of problems affecting the Riata models... other researchers have done additional tests and found incidences of wire protrusions [in Riata] running as high as 30 percent. The insulation-related problem appears to develop only after several years of implant and so its scope may accelerate as the devices age...Mr. Starks and other St. Jude executives have also accused Medtronic of carrying out a whispering campaign suggesting that St. Jude’s new Durata lead is prone to the same types of failures as the Riata... Some doctors say that the Durata’s improved coating may solve the problem and so far, data shows the device is performing. But Dr. Lau, for one, has already made his decision. “I have stopped implanting Durata,” he said."

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