st. patrick Posted October 26, 2005 Share Posted October 26, 2005 oh, a new member: dapper3dzapper . . . . kinda has a nice ring to it .. Quote Link to comment Share on other sites More sharing options...
customsteve01 Posted October 27, 2005 Share Posted October 27, 2005 Rick sorry to hear about your recall. Maybe you should tell them to install a zipper so you can do the next time. PM me your phone number, I moved it out of my inbox and can't get to it from home. We should be up in RI on Monday or Tuesday. Steve Quote Link to comment Share on other sites More sharing options...
NOSValves Posted October 28, 2005 Share Posted October 28, 2005 Well not me exactly, my zapper is being recalled.[:'(] I have an appointment with the technician to have it interogated every six months. She checks things like battery life, functionality and event memory. Today she called and told us that my appointment on Nov 16 has been rescheduled to a consult with a surgeon to schedule replacement surgury. It seems that the specific model defibrulator that I wear, St Jude Medical V-240, is, believe it or not, suseptable to cosmic radiation. I had read that last month and laughed. I wasn't planning any space trips in the immediate future. It seems under certain instances background radiation can effect an SRAM device in the circuitry which can cause the battery to deplete rapidly rendering the device inert. http://biz.yahoo.com/bw/051007/75217.html?.v=1 That's a real bummer!! This is hunting season!!! Now my wife will be worried again when I go out into the woods. That's why I got the darned thing! Hopefully, they won't be able to schedule surgery until after the season. err Christmas. Rick Rick, Remember all the problems with my Dad this spring..... Yup it was a faulty zapper that caused it all. We have signed up with a team of lawyers from CA for a class action lawsuit. I hope they fry them bastards! They knew of the defects in my fathers model long before the problems were brought out publically or even privately to the Heart specialists (they are none to happy about it either). His current zapper is the a watch recall also...... That is real comforting to know[] Everytime I see my dads number on the caller ID my heart drops into my stomach. Please don't mess around with this situation and do not trust the manufacturer. Is yours made by Guidant? Craig Quote Link to comment Share on other sites More sharing options...
3dzapper Posted October 28, 2005 Author Share Posted October 28, 2005 Mine is a St Jude V-240. Luckily it does not have the same problem as your fathers. I've been to my cardiologist and had a new echo today to see what type of ICD should go in when they take this one out. I'm just bummed that I have no control over this. If it were a normal low battery replacement, I could work with the doctors and my schedules. I don't know yet the timetable I am on and won't until the 16th. In the meantime I will have to cut a long planned hunting trip to Block Island short or at least take the ferry over, drive 40 miles,go for my consult, and return on the ferry to stay a few more days. Just the thoughts about this crap is raising my anxiety level to an unacceptable level. Rick Quote Link to comment Share on other sites More sharing options...
NOSValves Posted October 28, 2005 Share Posted October 28, 2005 Well what ever they come up with make sure it is not made by Guidant they can not be trusted. The company policy when they started seeing problems was well hopefully the defective units will get replaced in the normal low battery cycle before failure and we can just slip on through this with just a few fatalities. I know they just about killed my father. Craig Quote Link to comment Share on other sites More sharing options...
3dzapper Posted October 29, 2005 Author Share Posted October 29, 2005 No, it will be another St Jude, they are buying. The question is whether to install another single lead pacer/ICD or a dual lead pacer/ICD. The latter means inplanting a third lead. Rick Quote Link to comment Share on other sites More sharing options...
NOSValves Posted October 29, 2005 Share Posted October 29, 2005 My Dad's is a three wire. If you don't need it now you may in the future so it may be a good idea? Craig Quote Link to comment Share on other sites More sharing options...
Seadog Posted October 29, 2005 Share Posted October 29, 2005 Well what ever they come up with make sure it is not made by Guidant they can not be trusted. The company policy when they started seeing problems was well hopefully the defective units will get replaced in the normal low battery cycle before failure and we can just slip on through this with just a few fatalities. I know they just about killed my father. Craig FYI. October 28, 2005<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /> Guidant pledges better disclosure In letter to FDA, firm says it will give more product info to doctors, patients By Jeff Swiatek jeff.swiatek@indystar.com Guidant Corp., under fire for not promptly disclosing defects with its heart defibrillators, pacemakers and other devices, is promising to be more open. The Indianapolis medical device maker says it will provide a greater flow of information to physicians and patients. "We recognize the desire of the public to have even more information on product performance," the company said in a letter to the Food and Drug Administration. The letter, released Thursday, was sent to the FDA last month. Guidant said it will change product labels to better show reliability data for its devices and it will distribute reports about its products' performance more often and in greater detail. Those reports are posted on the company's Web site, www.guidant.com, said spokeswoman Annette Ruzicka. Guidant's pledge comes after disclosures last spring that it didn't tell doctors or patients about a rare but potentially fatal defect it knew it had in one of its heart defibrillator models. The problem led to the death in March of a Minnesota student whose defibrillator failed to respond with a life-saving shock when he suffered cardiac arrest. The company since issued five recalls for a variety of defects in more than 100,000 of its defibrillators and pacemakers that are implanted in patients around the world. Guidant's problems have threatened to stall its merger plans with New Jersey-based health products giant Johnson & Johnson. Last December, Johnson & Johnson offered $25 billion to buy Guidant, and the two sides have said they expected to wrap up the deal by last month. But last week, Johnson & Johnson said it is looking at alternatives to the merger as currently structured, because of the product quality problems Guidant has been having. And earlier this week, Guidant said it has been served with two federal subpoenas seeking documents, a development that might further delay the deal. Guidant's letter to the FDA shows that, within two weeks of being notified of 15 quality problems at its main pacemaker and defibrillator manufacturing site in Minnesota, it had drawn up a detailed response showing steps it would take to improve its systems. The 79-page response to the FDA's findings, following its inspection of the St. Paul plant, also was released Thursday. The document details the steps Guidant promises to take to fix the quality violations identified by FDA inspectors. "None of the problems impact the safety or effectiveness of products," Guidant said of the FDA-cited violations. Guidant released the responses, which normally are kept confidential, "to increase the flow of information with both physicians and patients," it said. Guidant said it is making "substantial progress" in carrying out the fixes. The violations cited by the FDA involved mostly quality- control issues. Ruzicka said Guidant "committed significant resources" to fixing the FDA-cited problems. "It has received our full attention," she said. Guidant's stock price Thursday rose 52 cents a share to $62.97, but remained well below the $76 takeover price. Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You can post now and register later. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.