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Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA
Date:2/25/2010

es were made to correct this flaw, according to the information.

In early 2004, Guidant allegedly discovered a similar short-circuiting problem with its Renewal 1 and Renewal 2 devices. Following the July 2004 death of a patient associated with a shorted Renewal in Spain, the information charges that Guidant knew that the physician operating instructions for responding to a short-circuit within the device were false and misleading. In an effort to remedy this, Guidant sent a communication by overnight delivery to physicians which the company dubbed a "Product Update." The information alleges that this communication was actually a correction to the device which attempted to mitigate the safety risk posed by the short-circuiting. Guidant was required by law to alert FDA of this action within ten days. The information charges that Guidant failed to make that notification.

Guidant issued safety advisories on the Prizm 2 and Renewal devices in June 2005. FDA classified those advisories as "Class I" recalls, the most serious classification of recall, concluding that there was a reasonable probability that the affected devices could cause serious adverse health consequences or death.

"The government charges that Guidant committed serious crimes by undermi
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SOURCE U.S. Department of Justice
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