Guidant has reported an additional 18 failures of its implantable cardioverter defibrillators (ICDs) in the past two months, according to an updated FDA public health notification.

The FDA's Dec. 28, 2005 notification follows its Oct. 13, 2005 and July 14, 2005 Preliminary Public Health Notifications (PPHNs) about malfunctions occurring with Guidant's Prizm 2 and Contak Renewal ICD devices, which were the subjects of a Class I recall announced by the FDA on July 1, 2005.

A device subject to the FDA's recall may develop an internal short and fail when it attempts to provide a defibrillation shock. Failure to provide a needed defibrillation shock is a serious, life-threatening event, the FDA said.

The FDA said Guidant informed the agency of 14 additional clinical occurrences exhibiting this failure mode for the Contak Renewal and Renewal 2 devices since the Oct. 13, 2005 PPHN. Guidant also has informed the FDA of four additional clinical failures for the Ventak Prizm 2DR, including one patient death, the agency said.

As of Dec. 21, 2005, a total of 32 clinical failures (of which FDA has confirmed 30), including 2 patient deaths, have been reported worldwide, according to the PPHN. There are likely to be additional clinical occurrences in the future, and the FDA will provide updates as this information becomes available, the notification said.

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