MASSDEVICE ON CALL — It was the death of a 21-year-old patient whose implanted cardiac defibrillator failed to shock his heart back to normal rhythm that started Dr. Robert Hauser on the path to becoming a vocal advocate for change at the FDA.
Joshua Oukrop, just a teenager when he received a Guidant ICD for a congenital heart condition, died when the implant shorted out instead of providing the necessary shock to his heart.
Hauser looked for answers to why the implant might have failed, discovering in the process that there had been 26 other failures for the same device reported to the FDA, he told CBS News.
"We eventually met with Guidant in May of 2005 – this would be three months after Joshua’s death – and we told them they were obligated to inform patients and physicians of the problem," Hauser told the news source. "They declined to do so. They stated that they were afraid physicians would overreact and take these devices out unnecessarily, because they believe that the likelihood of failure was very low."
Hauser took his story to the New York Times, he said, and the device was subsequently recalled.
For Hauser, the incident illustrates fundamental issues with the FDA’s oversight of medical devices, namely the fast-track 510(k) approval process that allows devices on the market without prior clinical studies and the lack of mandated post-market surveillance for high-risk devices.
Hauser is an active voice in the discussions surrounding medical device recalls and the review process. His most recent contributions include a report, driven by the FDA’s medical device adverse report database, on deaths tied to St. Jude Medical‘s (NYSE:STJ) Riata defibrillator leads, which are the subject of a high-profile recall that some say may pose a bigger risk than Medtronic’s (NYSE:MDT) Sprint Fidelis pacemaker lead recall.
Medtronic pulled its Sprint Fidelis leads from shelves worldwide in October 2007, but not before they were implanted in an estimated 268,000 patients. Because of fractures in the wires, defibrillators could either fail to deliver the shock needed to regulate a haywire heartbeat or send unneeded shocks. The defective leads were implicated in more than 100 deaths, although Medtronic has said that only 13 fatalities had the leads as a "possible or likely contributing factor."
Boston Scientific (NYSE:BSX) acquired Guidant in 2006 for $27 billion. After its May 2006 closing, Boston Scientific was forced to issue recalls or warnings on about 50,000 Guidant defibrillators, reporting that it might take two years to clean up the mess in Indianapolis.
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