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British Regulators Issuing Guidant Alert

Jun 23, 2005 | Star Tribune

British regulatory officials have held "urgent discussions" with Guidant Corp. in recent weeks regarding the company's delayed notice of problems with several models of heart defibrillators that may malfunction.

After a meeting in London on Tuesday, a spokesperson for the Medicines and Healthcare products Regulatory Agency (MHRA) said formal medical device alerts are being prepared for doctors in Britain regarding several models of implantable defibrillators made by Indianapolis-based Guidant. The company's cardiac rhythm management division, which makes the devices, is based in Arden Hills.

Implantable defibrillators stopwatch-sized devices that shock an errantly beating heart back into rhythm have been at the center of a controversy in the United States since May over when doctors should be notified about potential flaws in devices.

The British regulator says about 1,628 of the recalled devices have been sold in the United Kingdom although it is unclear how many of them have actually been implanted in patients.

Although Guidant fixed a short-circuit problem in its Ventak Prizm 2 DR (model 1861) defibrillator in April 2002, doctors in the United States were not informed about the problem until May 23. The next day, media reports surfaced regarding the flaw, which may have been a contributing factor in the death of a Grand Rapids college student last March.

MHRA said it was first informed by the company of the issue on May 25.

In a statement, Guidant said it "continues to work closely with its physicians partners, the [Food and Drug Administration] and other regulatory authorities to ensure proper reporting and communication regarding product safety."

The MHRA is a government body similar to the U.S. Food and Drug Administration responsible for ensuring that drugs and devices that reach the British market meet standards of safety, quality and efficacy.

MHRA expects manufacturers to immediately report any deterioration in the performance of a device that has led to the death of a patient or deterioration in a patient's health.

Additionally, if incidents occurring outside Europe lead to corrective action on devices sold within Europe, the MHRA says the manufacturer should notify the agency.

"MHRA were not informed in 2002 of design changes made to the [Guidant] device nor of any of the non-U.K. incidents that initiated the change process," said Gillian Peacock, MHRA press officer.

Peacock said there have been no adverse incidents regarding the recalled Guidant defibrillators in Britain.

The devices include the Ventak Prizm 2 DR (model 1861); Contak Renewal (model H135); and Contak Renewal 2 (model H155), which could short-circuit. Also, the Ventak Prizm AVT; Vitality AVT; Renewal 3 AVT and Renewal 4 AVT models may have a software problem that needs a programming change.

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