“Back in 94 I was laying down Christmas Eve and my heart started racing and when I got here my heart rate was 250 beats.” Ronald McClarin has a dangerous heart rhythm--which is why doctors put into him an ICD--an implantable cardioverter. It keeps his heart beating regularly…and shocks it when the rhythm has gone arhy.

But pacemakers and ICDs do fail from time to time.

There are more and more pacemakers and so called ICD’s—implantable cardioverter-defibillators used each year.

Still there is not a lot known about their reliability and how often they malfunction--something that could cause a very serious problem.

The latest review of data in the Journal of the American Medical Association shows us how often that truly happens.

Between 1990 and 2002, there were more than two million pacemaker implants and more than 400-thousand defibrillator implants in the u.s. 17-thousand of those devices malfunctioned.

In sixty one of these cases, the malfunction led to death.

Dr. Davendra Mehta, a heart rhythm specialist at Mt. Sinai Heart, says, “No level is acceptable because a defibrillator not working can lead to lethal consequences. But ah I think the level of below point three % had been accepted in the industry would be an expectable limit, anything above that would not be acceptable.”

The findings are a mixed bag. On one hand, the frequency of pacemaker malfunctions has diminished.

But the malfunction rate with ICDs is increasing…the rate being four times that of pacemakers.

More than half of the reported ICD malfunctions occurred in the last 3 years of the study. But another study suggests that the rate of malfunction may be dropping of late, after 2002.

The researchers write that because ICDs are substantially more sophisticated than pacemakers, it is not surprising that they have a higher device malfunction replacement rate.

The circuitry and memory have increased, creating a set up for more opportunities for failure.
Still, battery malfunctions were the most common cause of device failure.

And Dr. Mehta says, for the most part, they are, in fact, very reliable. “The reporting has become more stringent and the FDA is regulating them much better which is good for the industry, is good for the patients, and is good for the physicians.”

But patients can take matters into their own hands and follow up regularly with their doctor.

“We see these patients every 4 months unless they have had a shock. If they’ve had a shock and they are not feeling well, then we advice them to contact them immediately,” says Dr. Mehta.

Ronald’s ICD--now a smaller one--works great. “I never had no problems with it. I’m grateful for it,” he exclaims.

The authors point out that the chance that the device will save your life is about 1,000 times greater than the chance of the device failing when you need it.

Their success has led to the number of pacemakers being implanted each year increasing three-fold during the study period. The number of defibrillators implanted increased more than ten-fold.

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