Guidant recalls ICDs, sold some while aware of possible flaw.
The models affected are the Prizm 2 DR Model 1861 implantable cardioverter defibrillators (ICDs), manufactured on or before April 16, 2002, and two cardiac resynchronization therapy defibrillator (CRT-D) models, the Contak Renewal, model H135, manufactured on or before Aug. 26, 2004, and the Contak Renewal 2, model H155, also manufactured on or before Aug. 26, 2004.
Although the Prizm and the Renewal devices are subject to different forms of failure, these models all risk being unable to deliver the appropriate shock during an arrhythmia episode--which can lead to life-threatening complications. In two instances, the devices are suspected of having been associated with patient deaths.
According to Guidant there were 28 reports worldwide, including one that was linked to a patient's death, of a short circuit in the Prizm device that led to the diversion of the shock therapy away from the heart and into the device circuitry, leading to permanent loss of shock therapy and pacing. The company made manufacturing changes to prevent the problem on April 16, 2002, and again on Nov. 13, 2002. Guidant stated in a letter to physicians dated June 17 that no such failures have been observed in the devices built in the period between those two changes.
Guidant continued to sell the products manufactured before April 2002 and did not notify physicians of the potential risk. According to a report in the New York Times, it wasn't until the newspaper informed the company that it was preparing an article on the issue that "Guidant acknowledged that it had continued to sell the older, potentially flawed devices after the improved versions were available" (June 3, 2005, sec. C, p. 3). Guidant's letter said, "At that time data did not show an unusual failure rate and Guidant believed the device to be reliable."
In a statement about the recalls, the Heart Rhythm Society announced the formation of a task force on device performance.
The FDA, in its notification of recall, has advised patients to contact their doctors to determine if they have an affected device implanted. The agency is leaving the decision to have the devices removed and replaced between individual patients and physicians.
Guidant has agreed to provide a replacement at no charge for patients deciding to explant the Prizm 2 DR and will pay certain unreimbursed medical expenses providing the device was manufactured before Nov. 13, 2002.
The FDA also revealed that Guidant is recalling another set of defibrillator devices--all Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT--that are subject to a memory error that might affect performance. The FDA stated that it is evaluating the new information.
MARK S. LESNEY
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|Author:||Lesney, Mark S.|
|Publication:||Internal Medicine News|
|Date:||Jul 15, 2005|
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