Heart patients alerted to fault with US pacemaker

Up to 100 New Zealand heart patients could have had potentially faulty pacemakers fitted.

The Australian Government has issued a "hazard alert" for people who have a pacemaker implanted that could fail without warning.

The Government issued the alert for various models of the St Jude Medical Tempo Pacemaker with a warning the devices could fail unexpectedly. Some pacemakers may have to be removed.

Four faulty pacemakers had been sent back from Australia to the American manufacturer for further analysis, said Dr Graham Maynard, of the Therapeutic Goods Administration (TGA).

The company was working to identify which batch of the pacemakers was suspect, Dr Maynard said.

"What we do is go back to the manufacturer and ask them to tell us what the problem is," he said.

"What the exact problem is, is still being analysed. We don't know if it's all of them or just a few of them, or just a few made on a certain day. We're waiting."

Green Lane Hospital chief cardiologist Dr Warren Smith estimated between 10 and 100 people in New Zealand could have been fitted with the particular type of pacemaker.

"With this case, there is the potential for harm in some patients. It may be necessary to electively replace the pacemaker in people who are deemed to be at high risk.

"I think that will be a small number of people and that will need to be evaluated on a case by case basis."

If people were deemed high risk it was likely the pacemaker would need to be replaced within a week or so, he said.

Dr Smith said if people were concerned they could contact their local pacemaker clinic. Today the hospital would check all the files of people fitted with pacemakers and telephone them.

"One needs to move with reasonable speed on these things. It's not a panic or an emergency but once the concern is aroused, I think people need to know exactly where they are and what the advice is for them."

Dr Smith said pacemakers were reliable but they were made up of many components and there was always a small chance something would fail.

"For most patients, they are still safer with their pacemaker than without it, even if it has a fault."

A Ministry of Health spokesman said last night that the ministry was not in a position to comment but would follow the situation up with the TGA today.

A total of 994 Australians implanted with the St Jude Medical Tempo Pacemakers fell within the alert, Dr Maynard said.

Pacemakers might have to be removed from some of the patients depending on their doctor's assessment.

Patients who were "pacemakerdependent" were at greater risk than those who used them to boost a functioning but weak heart.

"The basis of our alert is that some pacemakers may be removed," Dr Maynard said.

A spokesman for Medtel, which distributes the St Jude pacemakers in Australia, said the TGA should not have issued an alert until it knew the exact batch.

Dr Maynard said the TGA had carefully considered its options before issuing the alert. "We try to balance the alarm versus the risk," he said.

He expected that more alerts - narrowing the number of people at risk - would be issued when the manufacturer had isolated the faulty batch.

Final results were expected within days, not weeks.

At least four notices of potentially defective pacemakers had been issued in the US by St Jude this year but Dr Maynard said they were for different models.

The US-based company reported in February that at least 90 of its pacemakers could malfunction and stop emitting the electrical signal that regulates heartbeats.

Spokesman Peter Gove said at the time that of the 891 pacemakers St Jude had identified as potentially having a problem, about 90 were affected.

He said the company was unaware of any patient injuries and the problems were not severe enough to warrant immediate removal.

St Jude is the United States' second largest pacemaker manufacturer.