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Help Support Valve Replacement Forums:
twinmaker
Well-known member
As a member here that is pacemaker and defibrillator dependent, I'm amazed when these companies recommend that instead of having these things replaced, they only suggest that patients see their doctors immediately to see if the device has malfunctioned already. Give me a break. Would you want to "wait and see" if your defibrillator doesn't restore a normal heart rythym or if you pacemaker stops working and you become unconcious possibly while driving your car? That's seems to be what manufacturer is suggesting.
LINDA
LINDA
MikeHeim
Well-known member
twinmaker-
On the other hand, do you really want to go through another surgery to have it removed if it is functioning perfectly? I believe that there are several people (Nancy's Joe, for instance - I hope I'm right about that) that are living with a mechanical heart valve that has been recalled (Bjork-Shirley, once again, if memory serves). Unfortunately, there are risks on both sides of the coin.
I work for a medical device manufacturer (dental products), and we have unfortunately had a few product recalls over the years. Very often, only a small number of the parts recalled are actually defective, but the entire lot is recalled as a precautionary measure. Of course, I don't know if that is the case in this instance, but it is a very real possibility.
On the other hand, do you really want to go through another surgery to have it removed if it is functioning perfectly? I believe that there are several people (Nancy's Joe, for instance - I hope I'm right about that) that are living with a mechanical heart valve that has been recalled (Bjork-Shirley, once again, if memory serves). Unfortunately, there are risks on both sides of the coin.
I work for a medical device manufacturer (dental products), and we have unfortunately had a few product recalls over the years. Very often, only a small number of the parts recalled are actually defective, but the entire lot is recalled as a precautionary measure. Of course, I don't know if that is the case in this instance, but it is a very real possibility.
twinmaker
Well-known member
Mike, as a matter of fact, I did have my defibrillator recalled and replaced last year after only having had it in for one year. I originally had a pacemaker implanted several years ago after an A-V node ablation for chronic A-fib which landed me in the hospital several times. An A-V node ablation usually makes you pacemaker dependent. Then on routine interrogation of my pacemaker, it was found that I was also having Ventricular Tachycardia which often is fatal. In other words, you usually die before the EMT's get to you. Therefore, my Electrophysiologist just about ORDERED me to have a combination pacemaker/defibrillator implanted. Mine was a Medtronic. After one year, it was recalled. The problem was a possible rapid battery depletion, most often without much notice. Because my device was relatively young (the problem was being found in older devices), I had a couple of choices...be followed closely by my cardio or get it replaced. When these recalls happen, a rep from the company also meets with a patient individually...at least that's what Medtronic did. He recommended I have it replaced. It was TOTALLY up to me and I had to sign papers as to what I could do, and what I was choosing to do. In other words, the company is covering it's behind. It ends up being on my shoulders. I wanted it replaced, and I couldn't do it fast enough. Having a minor problem is one thing, but having a device like these not work can be life-threatening. I weighed the risks of another surgery to my upper left chest (my third in five years) or taking my chances with a device that might not work when it was needed. It was an easy choice for me. I realize these are only machines made by humans and therefore are not perfect. My problems are with companies like Guidant that don't notify physicians or patients when there are problems. By the way, my first pacemaker was a Guidant and it was one that was eventually recalled. Medtronic (the maker of the last two devices that I had implanted) has been very upfront with notifying physicians and patients. Shame on those companies that try to hide it from everyone and put the almighty dollar above human beings. Sorry if this sounds like I'm preaching, but this is a touchy subject with me. LINDA P.S. My St. Jude mechanical mitral valve is still going strong after almost 25 years. Yeh!!!
Ross
Well-known member
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Guidant and FDA notified healthcare professionals and patients that a
subset of implantable pacemakers, cardiac resynchronization therapy
pacemakers and implantable cardioverter defibrillators [ICDs] is
associated with five reports of device malfunction due to the failure of
a low-voltage capacitor from a single component supplier. Patients with
affected pacemakers may experience intermittent or permanent loss of
output or telemetry or premature battery depletion. Patients with
affected ICDs may experience inappropriate sensing or premature battery
depletion. Physicians are asked to perform an exam as soon as possible
to assess device function for all patients with implanted devices from
this subset.
Read the complete MedWatch 2006 Safety summary, including links to the
firm press release, and the Guidant letters to physicians and patients,
at:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Guidant
Guidant and FDA notified healthcare professionals and patients that a
subset of implantable pacemakers, cardiac resynchronization therapy
pacemakers and implantable cardioverter defibrillators [ICDs] is
associated with five reports of device malfunction due to the failure of
a low-voltage capacitor from a single component supplier. Patients with
affected pacemakers may experience intermittent or permanent loss of
output or telemetry or premature battery depletion. Patients with
affected ICDs may experience inappropriate sensing or premature battery
depletion. Physicians are asked to perform an exam as soon as possible
to assess device function for all patients with implanted devices from
this subset.
Read the complete MedWatch 2006 Safety summary, including links to the
firm press release, and the Guidant letters to physicians and patients,
at:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Guidant
Y
Yaps
My freind who died, she had a pacemaker, I think it was a guidant, not sure..I will ask her son at funeral.....
twinmaker
Well-known member
Ross, It's nice to see that Guidant or should I say, Boston Scientific are following appropriate procedures concerning problems associated with these devices. I guess a lesson was learned in the past year and a half from not doing so. LINDARoss said:
