28 May 2005

IrishExaminer.com

WARNING: Heart patients may have faulty devices

28 May 2005
By Seán McCárthaigh

IRISH heart patients may have been fitted with potentially faulty medical devices implanted in their chests, it has emerged.

US medical equipment maker Guidant - which employs more than 1,000 people in Clonmel, Co Tipperary, - is facing a probe over its delay in alerting doctors about problems with one of its internal cardiac defibrillators.

Guidant has being asked by the US Food and Drug Administration to explain why it took more than three years for it to disclose a problem with one of its heart defibrillators.

The company is under investigation over why it failed to issue warnings to more than 24,000 patients worldwide and their doctors who have been fitted with its Ventak Prizm 2 Model 1861 once it became aware of the problem.

It is understood that some equipment has an electrical problem which causes a small fraction of the devices to short-circuit and malfunction. Implanted defibrillators are used to shock the heart back into a normal beating pattern after disruption to its usual rhythm.

A 21-year-old US student with a genetic heart disease died in March when his Guidant defibrillator failed to work during a sudden cardiac arrest while cycling.

The company was also aware of about 25 other cases of short-circuiting problems with the device, although none had fatal consequences.

An Irish Medicines Board spokesperson said 18 people in Ireland were fitted with the device. However, it said the failure rate of the product was just 0.05%.

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