Recently I described a later angioplasty to a surgeon where the incompetent cardiologist broke the coronary artery and I had emergency by-pass a few minutes later with a lot of running and shouting "Out of the way! Emergency!" This surgeon said, "That was lucky. It is usually a terminal event." This is better yet. Surgeons don't face death every day. They merely have to think of "Terminal events".
The NY Times today reported that...
"...Guidant has been under scrutiny since late May when it was disclosed that the company failed to notify doctors for three years that an electrical defect in one defibrillator model could cause it to short-circuit when needed to save a patient's life. The company continued to sell units with the potential electrical flaw even after it began producing improved versions of the same model in which the problem had been fixed."
The F.D.A. is investigating how Guidant handled reviews of its products' dangers. Since late May, the company has issued alerts or recalled 11 models of defibrillators."
Another site of importance is by the Medical and Heathcare Devices Regulatory Agency of the UK at: UK Agency
Dr. Bruce Wilkoff at the Cleveland Heart Center responded with the statement that...
"...Although under some circumstances all three types of devices can protect a patient’s life, defibrillators most specifically are used for this purpose. Therefore defibrillators are placed to protect patients from sudden cardiac death. Sudden cardiac death happens frequently in patients with heart disease. Although there are no guarantees with defibrillator therapy, it has been shown to be a very good, very effective and very reliable form of treatment. This is also true of pacemakers and biventricular pacing devicesNevertheless, occasionally a defibrillator, pacemaker or biventricular model will be identified as being potentially affected by a problem that could cause the device to fail and not protect the patient. Often the Food and Drug Administration (FDA) will call the situation a recall. However, each situation is different, and while sometimes the device will need to be removed and replaced, in the vast majority of situations THIS IS NOT THE BEST ANSWER.
Often, like the recent situations, the problem is so rare or so mild, that it is very unlikely to be harmful to most patients. In fact, all manufactured devices have a small failure rate..."."
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