FDA 483 - Unknown Company - February 09, 2006

The FDA conducted an inspection of Guidant Corporation, a medical device manufacturer in St. Paul, MN, from December 15, 2005, to February 9, 2006. The inspection revealed that the company had not adequately identified and implemented all necessary actions to correct and prevent the recurrence of nonconforming products, indicating a lapse in their quality system. A specific issue highlighted was an "analog to digital latching fault" in their Prizm I, Prizm II, and Vitality pulse generators, which could result in a loss of tachy therapy. This fault led to four confirmed and two unconfirmed field events since May 2002. Although a software fix was developed by May 2004 for a newer product design, the company delayed submitting this crucial correction to the FDA for certain *preexisting* affected devices until August 2005. This delay signifies a critical deficiency in addressing patient safety concerns. As an FDA Form 483, this observation requires Guidant Corporation to implement comprehensive corrective actions to address these findings and ensure full compliance with regulatory requirements governing medical device quality systems.