Wednesday, June 07, 2000 (from down under)

Heart pacemaker alert: fault may cause death By MARK METHERELL in Canberra

One thousand Australian patients with suspect heart pacemakers have been urged to see their doctors immediately after four of the devices were reported to have stopped operating.

The suppliers of St Jude Medical Tempo brand pacemakers issued a "hazard alert" yesterday for the implants, which maintain a regular pulse in patients suffering irregular heartbeat diseases.

The Therapeutic Goods Administration said St Jude models had been identified as having a fault "which can lead to premature, unexpected device failure".

The chairman of the therapeutic device evaluation committee, Sydney heart surgeon Professor Cliff Hughes, said it was likely that a majority of the estimated 1,000 patients with St Jude pacemakers would need to have them replaced.

Professor Hughes said all patients with St Jude pacemakers, supplied by Cardiac Rhythm Solutions Pty Ltd in Australia, should consult their doctors immediately.

Although he knew of no deaths associated with the reported failures, that risk remained if a pacemaker failed in a vulnerable patient. The more likely outcome was that patients would collapse as their pulse rate slowed. They would survive if given a replacement pacemaker urgently, he said.

Pacemakers, costing $5,000 to $6,000, are implanted in the chest and linked to the heart by slender electric leads. The highly sensitive devices are triggered by an irregular pulse to send a series of light electric shocks activating a regular heartbeat.

The problem with the St Jude pacemakers appears to be centred on what the company calls "premature battery depletion". The batteries normally last for five to seven years.

A clinical adviser at the Therapeutic Goods Administration in Canberra, Dr Graham Maynard, said problems with about 50 pacemaker patients worldwide, including four in Australia, had been linked with the United States-manufactured device.

He believed Australia was the first country to act on the St Jude problem, after a pattern of failures was picked up in routine record checks by the Therapeutic Goods Administration.

The executive director of the Consumer Health Forum, Mr Matthew Blackmore, last night called for a better system of recording problems with medical devices. The system relied on alerts by manufacturers but there was no legally required system obliging doctors to tell manufacturers of problems.

http://www.smh.com.au/news/0006/07/national/national26.html

-- Doris (reaper1@mindspring.com), June 06, 2000