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Surgeon criticises pacemaker company

By STEPHEN CAUCHI Saturday 17 June 2000

Unhappy: Heart surgeon Tony Wilson became concerned about pacemakers earlier this year. Picture: MATTHEW BOUWMEESTER A leading Melbourne heart surgeon has accused a pacemaker manufacturer of dragging its feet over issuing a recall, putting lives at risk.

A legal fight is also brewing over the cost of replacing the faulty pacemakers.

More than 1000 Australians, including hundreds of Victorians, have potentially faulty St Jude pacemakers. Two types are at risk: 992 of the "tempo" model and about 216 of the model meta 1256.

The director of the Cardiothoracic Surgery Department at St Vincent's Hospital, Tony Wilson, said yesterday he came across failed pacemakers earlier this year and realised they were the same model.

But despite alerting St Jude to the fault in early May and sending back three of the faulty devices, St Jude said it had not received the devices and were unaware of any problems, he said.

"I wrote to them on the first of May to St Jude ... and drew their attention to the fact that I was very concerned that we had a number of people in whom we'd found dead pacemakers," he said.

"I got a letter back 10 days later to say they had no record of any problems from our institution."

Mr Wilson said he next heard of the matter when Medtel Pty Ltd, the distributor of the pacemakers, issued a St Jude tempo pacemakers hazard alert on June 2. Earlier this week, an alert was issued for the meta 1256.

Mr Wilson said that when he contacted St Jude after the alert was issued, the company said, " we were just about to tell you".

The hazard alert means that all patients with the relevant pacemakers must contact their heart doctor for an appointment.

While only a small number are expected to fail, it is estimated about 10per cent of the pacemaker wearers will die if their device stops functioning. The other wearers, who have less serious heart problems, will experience symptoms such as dizziness and fatigue if their device stops. There is no way to tell if the devices will fail, said Mr Wilson.

Dr Peter Cashman, a partner with the firm Maurice Blackburn Cashman, said a class action was being prepared to launch next week in the Federal Court by "tens" of the pacemaker wearers. Many of the wearers had only been offered $600 and a new St Jude pacemaker, he said, when the costs of surgery would be several thousand dollars. The also wanted a different brand of pacemaker.

At the time of writing, St Jude had not returned phone calls from The Age.

http://theage.com.au/news/20000617/A12520-2000Jun16.html

-- (Dee360Degree@aol.com), June 16, 2000