The Guidant Corporation finally alerted physicians that it had nine "older pacemaker models (which) were prone to failing". The company, which is already in a controversy over earlier recalls of its units, said that some implanted units might need replacing. If you don't have one yet and work at your desktop PC or Mac instead of keeping it in your chest; you have no worries.
Guidant alerted doctors to the failure possibility in the 28,000 made from November, 1997 to October, 2000. That was a bad year to be dying of heart problems, obviously. In a capitalist world you should have had the foresight to get your pacemaker from a different company or at a different time. Shame!
The problem is "...that a component used to seal the pacemakers could degrade...causing the devices to fail. Such failure could cause 'serious health complications' in some patients." This problem follows Guidants recent recall of "tens of thousands of implantable heart defibrillators..."
I love medical euphemisms. I mention it because I have a second "pacing device" implanted and made by Guidant. It is a "bi-ventricular pacing device " and has a built-in defibrillator.
The euphemisms, however, often make me laugh—or something. In 1994, 2 days after a massive heart attack, my body (or a medical error) caused cardiac arrest. I was about to be transferred from intensive care and was sitting up eating a great-looking chef salad when I felt so badly even I knew it was time to ring the bell. It was one of the hardest things I had ever done—raising my hand high enough to bring it down on the old-fashioned bell.
Some time later, after some excitement that I was not on this planet to see, I looked up at an expectant team of six people and said "thanks". A joke seemed out of place and letting them know I was happier in the other realm would have negated their pride. I asked my nurse later, "What happened?" The reply: "Oh, we just lost your pulse for a while." Wow! Think of the things that can now be lost and found again.
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
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