When they implant a pacemaker that has been recalled . . .
This recent forum exchange involves a woman who has had problems with her pacemaker since the day it was implanted, 9 months ago. Here's what happens when she discovers, from this forum, that her particular pacemaker had been the subject of an "advisory" one month before it was implanted.
Medical terms:
rate response: today's pacemakers can sense the body's level of activity and increase the rate of pacing when the patient is active. This ability is called "rate response."
From: Pacegirl
To: HeartDisease.Guide
Hi Dr. Rich,
I have a question for you please. I have a {specific model} pacemaker set in the
DDDR mode. I have had problems with the rate response since it was implanted in
April 2000. The settings have been changed numerous times to no avail. It is set
on the most aggressive setting to increase the rate with activity. The problem
is it hasn't made any difference. It usually won't pace higher than the 70's
even with moderate exercise. My previous pacemaker was from another company, and
I had no problems with the rate response. I'm pacemaker dependant. Any ideas or
suggestions? I'm tired of being left short of breath and tired because of this.
From: HeartDisease.Guide
To: Pacegirl
The rate response in this particular pacemaker is mediated by an accelerometer. An accelerometer is basically a tiny electronic component that senses the degree of vibration in the body (when you move, it causes the tissues of the body to vibrate) and increases the heart rate in proportion to the amount of vibration (and hence the amount of movement).
In other words, this is a very simple process. One way to test the competence of the "motion sensor" is simply to tap the pacemaker itself with your finger. The heart rate should noticably increase. If not, then there's very likely a pacemaker malfunction. Your problem sure sounds like a pacemaker malfunction.
After I got your post, I did a quick check, and sure enough, in March, 2000 there was an "advisory" issued for the model of pacemaker you received, notifying physicians about a potential problem with the rate response processor in this pacemaker. Here's the link:
http://www.medical-devices.gov.uk/pt_nts.htm
Note: this link is from the UK, and I don't know if a similar "advisory" was posted in the U.S. Should have been, but if it wasn't mandated by law maybe it wasn't. This particular problem, by the way, may be entirely unrelated to what's happening with YOUR pacemaker. Indeed, this notice was published in March, a month before your implant, so odds are your device doesn't have this "feature." But this notice still is powerful ammunition.
In any case, your doc should have been all over this. No excuse for a rate-responsive pacemaker not doing rate response - that's something that HAS to be fixed. Your doc and the St. Jude people may owe you big time.
It's time to scream bloody murder. Call your doc. Tell him you found a "recall" notice. (That's not really what this is, but it's close. And the word "recall" will get his attention.) You want clarification and resolution of this matter NOW. Is he going to call the company rep, or should you do it? (He'll do it.) And why did YOU have to bring this to HIS attention? Shouldn't that work the other way? You (or somebody) paid big bucks for this feature-laden pacemaker, and the one feature you really need doesn't work. You are REALLY, REALLY disappointed, upset, not sure what to do or who to call (he's thinking: lawyers), etc., etc.
You should get pretty quick action. It truly is a shame your doc hasn't tracked down the problem by now. That's his job. Even if it turns out to be something else, it's fair at this point to light a fire under him.
Best of luck,
DrRich
From: Pacegirl
To: HeartDisease.Guide
Hi Dr. Rich,
Thank you SO much for your timely response. I looked at the site and sure enough
the specific model number of my pacemaker is listed on the advisory. I take it
to mean that this pacer should never have been left in the hospital stock for
implantation.
I did what you suggested by tapping the pacer and I didn't notice a rate
increase. If I jump up and down or jiggle it forcefully then the rate goes into
the high 80's. Walking even at a fast pace isn't enough to make it rise. I was
helping one of our docs push a patient to radiology and we were walking very
quickly. (I'm a nurse.) I felt so horrible I had to sit down.
I have had several pacemaker operations, with a lot of problems. When I had this pacemaker inserted in 4/00, I also had quite a few problems. The surgery itself was complicated. They had to change leads, and I got a different pacemaker than the one they were originally going to put in. I'm still so angry at times and the idea of possibly more surgery because of this rate response makes me even more angry and a little worried although I trust my surgeon completely. Part of me wants to sue but I'm not the type of person to sue someone at the drop of a hat. What do you make of all this? I'm sorry this letter turned out longer than anticipated. Thanks for taking the time to read this.
From: HeartDisease.Guide
To: Pacegirl
Quite a story.
If I were you, I'd want a full explanation of what's going on.
1) Why did they implant a pacemaker with known, published defects? (Warning published in March, pacer implanted in April.)
2) Why are they still puzzling over the lack of rate response (scratching their heads, reprogramming, tsk tsking, etc.) when the pacer is KNOWN to have problems with rate response due to bad components?
I'd start with your surgeon, who you trust and who probably doesn't know anything about the product advisory. Print out a copy from the link I gave you, and take it or mail it to your surgeon. Tell him you'll be contacting him in a few days for a full explanation after he's had a chance to track everything down. Among the things you expect him to answer after doing his research are questions 1 & 2 above. If he's an honest player here, he ought to be outraged.
The third question you need answered is: what do they propose to do about it? It seems to me that replacing the pacemaker with one that works right is what you need. Given the special problems you've had with the surgical site, however, this might not be a straightforward option, so you need to discuss with your surgeon the possible means for doing this (using the same site, vs starting over with a new site and removing the existing leads). Either way, it won't be easy on anybody.
If you can establish that the company really did allow the surgeon to implant a device that they knew to be prone to this problem, then the company ought to suffer some consequences. If you don't want to sue (and far be if from me to encourage anyone to sue), then you at least ought to make sure the FDA knows about this. How many other patients might be suffering from the same "oversight?" Your surgeon should take the lead here, but if he is unwilling then you can do it yourself.
I'd sure be interested to know the outcome. Keep us posted, if you're willing to do so.Come on in! The forum's fine!
