Guidant Cited for Manufacturing ViolationsFeb 23, 2006 | AP
Medical device maker Guidant Corp. waited more than a year to tell federal regulators that it had repaired software in a line of defibrillators, according to inspection documents released Thursday.
An inspection report by the Food and Drug Administration said a flaw in Prizm, Prizm 2 and Vitality pulse generators caused the defibrillator to stop regulating patients' heart beats.
Indianapolis-based Guidant developed software to fix the problem in May 2004, but did not submit the change to the FDA until August 2005, inspectors said.
Inspectors discovered the omission this month as part of their 21-day examination at Guidant's St. Paul, Minn., facility.
Fred McCoy, head of Guidant's cardiac division, acknowledged in a deposition last month that the company also did not get FDA approval to fix possibly fatal problems in Ventak Prizm 2 Model 1861. Of the two changes Guidant engineers made to that defibrillator, only one was disclosed in company filings.
The company waited three years to disclose problems with the defibrillator.
The FDA, U.S. Department of Justice, the Securities and Exchange Commission and several state agencies are investigating Guidant over its recalls this summer.
Since June, Guidant has issued recalls or safety advisories for 88,000 defibrillators and more than 200,000 pacemakers. At least seven deaths have been linked to the devices.
The company also faces 60 class action lawsuits and another 145 individual suits from its recalls.
In a statement, Guidant executives said they would file a response to the FDA's latest finding by early next month.
"The company has already completed much of the work it believes is required to address the observation on a system-wide basis," officials said.
Guidant's St. Paul facility has been the focus of the federal investigations and inquiries into the company's manufacturing process.
In late December, the FDA sent Guidant a warning letter saying the company failed to resolve all the problems the agency discovered during an earlier inspection.