FDAnews Device Daily Bulletin


Dec. 15, 2005

Guidant recently reported an increase in the number of deaths associated with use of its Contak Renewal and Renewal 2 heart devices.

In a recent product report, the company notified the FDA that five deaths have been associated with use of these devices through August 31. These updated reports show three more deaths associated with these implantable defibrillators and cardiac resynchronization therapy defibrillators since the company recalled the devices in June.

According to a company statement, this additional data was released as part of an enhanced product performance report to the agency "containing an unprecedented level of information related to product performance, including confirmed failure details by product family." The deaths have been linked to short-circuiting of the devices, the company said.

The company added that it continues to update its device reporting because "the health and well being of patients is our highest priority. Therefore, the company continually collects and analyzes information about product performance through field observations and other quality metrics."

The updated product reports are available at www.guidant.com (http://www.guidant.com).

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