FDA REPORTS MORE INSTANCES OF ICD FAILURE
The FDA recently updated its health warning for two of Guidant's implantable cardioverter defibrillator (ICD) devices because six additional product failures have occurred since the last warning.
The agency announced recently that there have been six failures of Guidant's Prizm 2 and Contak Renewal ICDs since the FDA originally issued warnings on July 14. As of Oct. 7, these failures bring the worldwide total for the devices to 21 clinical failures and three deaths, the agency said. "You should take these failures into account as you continue to follow the patients who retain either device," the FDA noted.
The agency recently approved a modification to the two devices that would reduce the likelihood of failures in newer devices. The modification involved replacing the insulating material on the feedthrough wires with a different insulating material that has better degradation properties