Implantable Cardioverter Defibrillators Can Fail

An implantable cardioverter-defibrillator (ICD) protects many patients with serious heart problems against a life-threatening abnormal rhythm. The device delivers a strong electric shock to stop the dangerous rhythm. It is estimated that about 125,000 new ICDs are implanted annually in the U.S.

These devices have been demonstrated to improve survival in patients at high risk for sudden cardiac death. As you can imagine, however, complex medical devices like ICDs can malfunction. For example, in June 2005 alone, one manufacturer voluntarily recalled about 62,000 of its ICDs due to safety problems. The difficulty for the patient is that such malfunctions must be reported to the U.S. Food and Drug Administration and to doctors, but not to patients with an ICD in place. This type of reporting would be similar to an auto maker telling the dealer who sold your car, instead of you, about a recall of cars with a brake problem.

What can you do if you have an ICD? You shouldn't lose any sleep worrying about whether your ICD will function properly because these safety problems are usually minor, and serious malfunctions are rare. But, if you hear about the recall of any ICD, I suggest that you call your doctor to find out whether you have one of the recalled devices.