arlo 0 #1 June 17, 2005 i read something about this several weeks back. i think each side had a valid point. there may be more harm than good by going in and replacing the pacemaker, so please just read it for information to talk to your doctor about. thanks! arlo ================================ WASHINGTON (AP) - Heart patients using implantable defibrillators that have been recalled need to contact their doctors to determine what to do, the Food and Drug Administration recommends. Guidant Corp. announced Friday that it is recalling three types of defibrillators that can develop an internal short circuit and then fail to deliver a shock when needed. Implantable defibrillators are intended to sense an irregular heart rhythm and shock the heart back into correct beating. The FDA said it "is not making a recommendation on whether individual patients who have one of the Guidant devices should have it removed and replaced." That decision needs to be made by the patient and his or her doctor depending on the individual situation, the agency said. Replacement of the defibrillator may pose a risk. The FDA advised patients: If you have not already been notified, contact your doctor to determine if you have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device. Continue to keep your regular doctor appointments. If you feel an electrical shock from your device, immediately contact your doctor. If there is an audible "beeping" from your CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean that your defibrillator is damaged. "FDA's first priority is patient safety. We want to ensure that all patients who may be affected by this problem are notified and seek appropriate medical advice from their physicians," Dr. Daniel Schultz, director of FDA's Center for Devices and Radiological Health, said in a statement. Defibrillators covered by the recall are the Guidant PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002; CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004; and CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004. 06/17/05 15:16 EDT Quote Share this post Link to post Share on other sites
mailin 0 #2 June 17, 2005 This pisses me off - St. Jude recalled models back in 2002. Medtronic recalled theirs in March and now Guidant is recalling them... Who's gonna get it right? Those are the only 3 manufacturers! And the fact that with this one, Guidant knew about the problem but still had the defective units put into people makes me sick. When these recalls happen they have to replace the whole unit - not a 'small' thing by any means JenArianna Frances Quote Share this post Link to post Share on other sites
kelel01 1 #3 June 17, 2005 Yeah . . . my sister's pacemaker broke when she was 2. It's definitely a big deal. 9 times out of 10, they can't fix it from the outside. Quote Share this post Link to post Share on other sites
mailin 0 #4 June 17, 2005 I think the funniest thing about it is when they tell you: "No need to worry, the company will pay for the entire replacement" Woohp-de-fucking-doo - the hospital and my insurance company see all of that, how about that 'pain and suffering' stuff. You're pretty much immobile for almost 6 weeks after that surgery - who's gonna pay for that? Sorry, this just makes me mad JenArianna Frances Quote Share this post Link to post Share on other sites
kelel01 1 #5 June 17, 2005 No need to apologize. Your anger is deserved. Quote Share this post Link to post Share on other sites
kbordson 8 #6 June 17, 2005 Yeah... it's easy to blame the manufacturer.... all their fault. They are just looking for the bottom line. They don't care about the patient.... Come on. Get real. We, as a society in the US, have come to a point that we tend to expect WAY too much. Yes, it's a burden to have to go back to surgery.... the risks associated with that, the impact that it has on life, but the alternative is? Not doing it. Prior to any surgery, you should get counseled on the risks, benefits and alternatives of the procedure. Risks include device failure, recall, risk of re-operation, risk of surgical complications..... for a benefit of living longer or having the reassurance of the device to restart your heart if it stops..... the alternatives? - not doing the surgery is one of them. With that comes the risk of natural course of what ever disease you might have. But we tend to think of that as not an option anymore... even though 250 years ago that was the ONLY option. Medicine has made such stides in the past centuries that we now take it for granted and assume that everything has to go perfect or else it has to be someones fault. But think back Anesthesia was just discovered in 1846 XRays in 1890's Penicillin in 1928 and prior to Pasteur, Semmelweis, and Lister to try to keep things clean.... medicine was just as dangerous as skydiving (not to start a debate on if skydiving is dangerous) Implantable defibrillators are as young as 1980's These are relatively new advances that everyone just assumes as a part of "modern medicine" So now, we have an average life span in the 70's, we can cure many types of cancers, we can break many (sometimes too many) bones and still life a normal life. And we expect that some pill will fix this or a surgery will correct that. So with that complacent attitude, people then eat at Mickey D's (just tuck that lipitor right in the Big Mac) and sit on their duff and watch Oprah with disgust about how it's so horrid to have to endure this that or the other. But just remember..... doctors just practice. Not always getting it right, and even the best medical knowlege might be wrong. Even the "perfect pill" or device might be snake oil or recalled. Who knows.... Leeches might be the real answer (or not....) I sometimes wish that I could see where we'll be in another 250 years.... anyway... I was just annoyed by the automatic attitudes against the manufacturers and the medical community. But being in the field, I am biased.... (enough venting now.... carry on) Karen Quote Share this post Link to post Share on other sites
f1freak 0 #7 June 17, 2005 You are sooooo on the money with what you said... it's not just the medical field either, The expectation of perfection is just not realistic. People (and yes manufactors are people...) in fields like medicine dont "try" to make a bad product, what bennifit would that be to them. it's just life. I can't think of anything man made that hasnt been changed, upgraded..... what ever.... We learn more and more every day, and thats good. to use this as an example, people whou got pacemakers now will have the bennifit of newer technology than the others...... Nothing will EVER be perfect, but i am glad we have people that will always shoot for perfection everyday.....HAVE FUN... ...JUST DONT DIE Quote Share this post Link to post Share on other sites
