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American Morning

Study Reveals Problems With Heart Pacemakers and Defibrillators

Aired August 15, 2001 - 10:19   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
DARYN KAGAN, CNN ANCHOR: Medical news for you now. A new study revealing problems with half a million heart pacemakers and defibrillators over the past 10 years.

We get the details now on the story from our medical correspondent Rhonda Rowland -- Rhonda, is your pacemaker, if you have one in your chest, I think there's reason to be concerned.

RHONDA ROWLAND, CNN CORRESPONDENT: Well, there is. It seems that there are a lot of problems. It's almost like when you buy a car you can expect you're going to have to go in for tune-ups or maybe some recalls. It's the same thing with these kinds of devices. And what we're talking about here are, again, the pacemakers, and they're very small devices and they're designed to regulate a heartbeat. And implantable defibrillators. And they're designed to shock the heart into action if it slows down too much and they're, they can prevent sudden death. And as you may recall, Vice President Dick Cheney had one of these devices implanted.

So they are wonderful devices, Daryn. They can save lives. But there are problems.

KAGAN: But when there's problems, to continue our analogy to the car, it's one thing to take your car into the garage, it's another to have something in your chest that's not working.

ROWLAND: That's right.

KAGAN: So what are you supposed to do?

ROWLAND: Well, first of all, if there is a problem what happens typically is the manufacturer will contact the doctor and the doctor will look at his patient records and see which particular patients have these particular devices. And if it seems real serious they may bring them in, do some external monitoring. They may have to go in, do a little tweaking, a little surgical kind of procedure. But this is something, Daryn, where we don't really want to frighten people because there is a safety alert. Maybe it affects one percent of the patients who have this particular device. But the doctors are monitoring. They may bring you in.

KAGAN: Also, the progress here. It seems that these are getting better and better, but as they do, is there a rush to get these things approved and maybe they're getting approved before they're really ready for mass production?

ROWLAND: Well, that's what these researchers publishing the study in the "Journal of the American Medical Association" say. They think that maybe because there's so much demand, doctors want more sophisticated devices, the manufacturers certainly want to bring them out there, sometimes they're studied for only 12 to 18 months. But when you put them in a patient, they may wear these for five or 10 years. So maybe they need to slow down and take more time in developing them.

So, that's one solution. Also, Daryn, they're maybe saying a little external oversight by some non-biased parties, maybe the American Heart Association, the American College of Cardiology, to kind of oversee this a little bit so it's not just in the hands of the manufacturers.

KAGAN: Yes, but if you have any kind of concerns, I guess contact your cardiologist.

ROWLAND: And definitely. And you may never even know there's a problem. It's all whether or not your doctor brings you in. They may not even bring it up. They may just do a little monitoring. So again you don't want to be fearful, but know that sometimes there are these recalls and your doctor is usually alerted to them.

KAGAN: Rhonda Rowland, thanks for explaining. We appreciate it.

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