Wednesday, July 20, 2005

Guidant Recalls Heart Device

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 controverisal situation 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. (I will shortly give a short course on carrying your palmtop in your chest.) 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 clod 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." For the busy physician with life and death on his hands, he can stop worrying about patients dying. They merely expepience "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."

See NY Times.

Another site of importance is by the Medical and Heathcare Devices Regulatory Agency of the UK at: UK Regulatory Agency.

Dr. Bruce Wilkoff at the Cleveland Heart Center responded with a concise description of the types of implanted devices and 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 devices.

Nevertheless, 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..."

See Dr. Wilkoff's article and description of the major types of implanted machines at Cleveland Heart Center.

For an informative and fun version of pacemakers and their invention - by accident - by Wilson Greatbach in Inventing Modern America by David E. Brown which presents an anthology of fascinating inventions and their stories. Great for non-science types and wonderful for young people with an interest in invention and science. It is availably here and on my photoblog through Amazon and its own website at Inventing America. There is a great article on the World Wide Web and the first Apple, too.

The three implantable machines are a pacemaker which is smaller and "prevents the heart from going to slowly."

"DEFIBRILLATOR (ALSO CALLED AN ICD): This device is a bit larger and includes the activity of the pacemaker but also watches the heart for sudden fast heart rhythms." I had one of these for a time and it kept me alive and, here in the Mexican jungle; was there in case of cardiac arrest where you have a few minutes to get to a defib device and the closest is at least a half hour away, maybe four (if it is working and hasn't been stolen)

And, as I have now which is helping amazingly: a Guidant "BIVENTRICULAR PACING OR CARDIAC RESYNCHRONIZATION DEVICES: These devices treat heart failure, a condition when the heart does not pump enough blood to the body. These devices are either a pacemaker or a defibrillator but also have an extra lead (wire that goes from the metal device to the heart). The extra lead activates another part of the heart (left ventricle) which improves the efficiency of the heart to squeeze out more blood with every heart beat"

Am I worried about the recall? Not really. It is working, I haven't been notified and my mood doesn't include the surgery to change the one I have. Should these devices be watched more and more carefully as they multiply and become progressively more sophisticated? Absolutely!