[May 09, 2006]

So can YOU trust your pacemaker?

(Daily Mail Via Thomson Dialog NewsEdge)DUNCAN GRAHAM-ROWE, 36, a freelance journalist, explains how he discovered that the pacemaker that was supposed to keep him alive had a dangerous fault - one which could affect thousands of other people.

TWO months ago I exercised my consumer rights by returning a device I considered to be faulty. The trouble is, unlike your average toaster, mobile phone or iPod, I first had to have it surgically removed.

The device in question was an implantable defibrillator - a sort of suped-up pacemaker - which was designed to sit in my chest and shock my heart into beating properly whenever necessary.

For the past four years it appeared to have been doing its job - I was still alive after all - and on the whole I considered myself very fortunate to have one.

Last October, however, I was alarmed to receive a letter from my doctor informing me that not only was there a known fault with my particular model, but at the time of my implantation the manufacturer, Guidant, had already been aware of the fault and yet had failed to inform me or my doctor about it.

The news took my breath away - for it has huge implications.

More than a hundred thousand people had been fitted with the same device or similar ones for a wide range of cardiac conditions.

At least 2,000 of these reside in the UK - and many won't know about the fault.

In my case, the defibrillator is the only known treatment for a genetic condition I have called Brugada Syndrome, which can sporadically affect the electrical activity of the heart, sometimes fatally. My device sits there waiting for a Brugada attack so it can deliver a lifesaving electrical jolt to my heart.

The nature of the syndrome means that I can go several years without an attack, but when I do I need to know the device will work. Now I was being told there was a chance it may not.

As it turns out, some other patients got an even rawer deal. It has emerged that in 2002, a month after my implant was fitted, having recognised how serious the fault was, the company changed the design on all new devices.

Quite right, too, except for the fact that for some reason, known only to Guidant, the company decided not to notify doctors of the problem in the older devices.

In essence, this meant some cardiologists around the world were unwittingly implanting devices in people which Guidant knew were prone to a potentially life-threatening malfunction, but for which it had a safe alternative.

In fact, the company kept quiet about it for three years and we would probably still be none the wiser if it weren't for the fact that people started dying.

The first was Joshua Oukrop, a 21-year- old student from Minneapolis, who died a year ago while he was mountain biking.

Oukrop had a condition called hypertrophic cardiomyopathy which was being treated with the same type of defibrillator as I had - a Ventak Prizm 2 DR - but which failed to deliver a shock sufficient to correct a sudden abnormal rhythm.

It is possible that others died under similar conditions before him, but because the devices are not routinely checked after a death, it is impossible to know.

SINCE Oukrop's death, however, there has been greater vigilance and two additional deaths have been linked to the Prizm 2 DR while another five deaths have been tied to its sister product, the Contak Renewal.

So it should be no surprise that the company now faces multiple lawsuits from nearly 2,000 patients and relatives in the U.S. Meanwhile the U.S.

Department of Justice and the U.S. Food and Drug Administration-FDA) are carrying out criminal investigations into the company's behaviour.

Yet in Britain, remarkably, this issue has barely made a ripple.

If a car manufacturer discovered a fault with a braking system, fixed the problem but carried on selling the old faulty ones, there would be a public outcry.

And the fact that it could happen at all would be a clear indication of a lack of oversight by regulatory authorities. Indeed, herein lies the problem.

Once a product is on the market, the industry effectively regulates itself.

The UK's Medical Devices Agency, although carrying out an investigation into the company's conduct, seems completely dismissive of the issue.

And the advice it is giving cardiologists is that instead of removing the defibrillators, they should check them more frequently - every three months - for any signs of malfunction. Given the random nature of the fault, however, no amount of monitoring will tell you when it is going to fail.

The company argues that not all of these devices are prone to this fault and even then there is only a small chance of failure.

But from a patient's perspective, all 109,000 of these devices from this potentially dodgy batch are as good as useless. Because if you can't be sure that it's going to work when you need it, there is absolutely no point in having it.

So I decided to have mine replaced, and needless to say when choosing a new one I opted for a different make.

But a large number of people who are older than me or in some way too frail to undergo surgery are now stuck with the device. These people have the right to know that their lives are under threat.

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