FDAnews Device Daily Bulletin

FDA UPS RISK OF GUIDANT DEFECTS

June 26, 2006
A A

A potentially deadly short-circuiting problem with implantable defibrillators made by the former Guidant Corp. may be far more common than initially indicated, according to an analysis by federal regulators. Guidant's implantable heart devices may fail about 10 times more often than the company had projected last year, according to a U.S. Food and Drug Administration analysis released in a Texas lawsuit. A judge in a product-liability lawsuit involving Guidant's defibrillators recently unsealed the FDA document dated June 16, 2005. Pioneer Press (http://www.twincities.com/mld/twincities/14880994.htm)