Medical Device Daily Associate

FDA inspection documents released Thursday show that Guidant (Indianapolis) waited more than a year to tell federal regulators that it had repaired software in a line of its defibrillators,.

The report said a flaw in Prizm, Prizm 2 and Vitality pulse generators caused the defibrillator to stop regulating patients' heart beats.

The company 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, Minnesota, facility, which took place between Dec. 15, 2005, and Feb. 9, 2006, and issued the company a Form 483 noting the inspection observation.

The facilities are used to make heart rhythm management products, such as pacemakers and implantable cardioverter defibrillators (ICDs).

Fred McCoy, head of Guidant's cardiac division, ac-knowledged 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.

In his deposition, McCoy acknowledged the company made changes to one of its defibrillators in 2002 and later incorrectly told federal regulators it had no effect on the product's performance.

Still, McCoy said, he didn't think the faulty defibrillator was responsible for patients' deaths.

“This particular failure mechanism does not have the capacity to kill a patient,“ he said. “It may be unable, as a device, to save the patient.“

McCoy said he wasn't told about problems with the devices until May 2005. He also said if he were a patient about to receive one of the devices, he would not want to know if it had a specific problem that could be deadly.

“As an individual, I would not want to know,“ he said. “But I can concede many would.“

The FDA, U.S. Department of Justice, the Securities and Exchange Commission (SEC) and several state agencies are investigating Guidant over its recalls this past 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, according to documents filed this week with the SEC.

In that filing, Guidant said that as many as 2,500 patients may seek damages after last year's recall of 109,000 implantable defibrillators linked to at least seven deaths.

The company also said in the filing that it learned last month of about 1,700 claims, and said it expected more. Those claims are distinct from those of patients already participating in 211 individual and class-action lawsuits in the U.S. and Canada, the company said.

Guidant had a $113 million charge in 2Q05 for the cost of replacing the recalled defibrillators

In a company statement relating to the Form 483, 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.

In its statement, the company also said it anticipates being ready for the follow-up inspection by mid-2006.

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.

The company noted that the inspection was not an assessment of the adequacy of its response to its Form 483 dated Sept. 1, 2005, nor its warning letter dated Dec. 22, 2005.

This latest news for Guidant comes at a time when Boston Scientific (Natick, Massachusetts) is trying to close its $27.2 billion acquisition of the company, which the parties hope to close by end of March. That deal still must be approved by shareholders and by regulators in the U.S. and Europe.

No Comments