Warning issued on faulty heart device

A warning about the failure of heart pacemakers by a US manufacturer is likely to affect fewer than 100 patients in the Republic…

A warning about the failure of heart pacemakers by a US manufacturer is likely to affect fewer than 100 patients in the Republic.

The Guidant Corporation yesterday alerted doctors that some 28,000 pacemakers, manufactured between 1997 and 2000 and implanted in patients, were prone to failure because a component used to seal them could degrade. It said 18,000 devices had been implanted in patients in the US.

Cardiologists in Ireland estimated that fewer than 100 people would have received a Pulsar pacemaker, one of nine older types involved in the warning.

They said each pacemaker has a unique identifier linking it to the recipient, and anyone with a suspect device will be contacted by their specialist or the hospital where the device was inserted.

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A pacemaker regulates a heart beating too fast or too slow. It is implanted under the skin in the chest wall. A wire connects the pacemaker box with one of the chambers of the heart. When an abnormal rhythm is detected, the device "kicks in", restoring a regular heart beat.

The manufacturer said it had identified 69 of the 28,000 pacemakers that may have had the seal problem. In 20 cases, the problem caused the pacemaker to fail. Some five patients lost consciousness as a result, but no fatalities were reported by Guidant.

Because of their age, many of the pacemakers would need routine replacement soon, as their battery life comes to an end. Patients dependent on a suspect pacemaker will probably be advised to have it replaced, but this will be decided on a case-by-case basis.

Dr Brian Maurer, medical director of the Irish Heart Foundation, yesterday advised patients who know they have a Pulsar pacemaker to contact the cardiologist who inserted it or the hospital cardiac department where the procedure was carried out. - (Additional reporting New York Times)