Riata / Durata More Bad News!!!!

Discussion in 'St Jude Medical' started by Anonymous, Sep 29, 2011 at 10:50 PM.

  1. Anonymous

    Anonymous Guest

    Insulation Defects of Thin High-Voltage ICD Leads: An Underestimated Problem?
    September 20, 2011 0 Comments
    Insulation Defects of Thin High-Voltage ICD Leads. Background: Long-term lead failure is a known complication of ICD therapy. The precise incidence and sequelae of insulation defects at the tricuspid level, however, are not well characterized.
    Objective: This study determined the risk of lead failure, with particular emphasis on insulation defects at the level of the tricuspid valve, in a large series of consecutive ICD recipients.
    Methods: Data from 357 consecutive patients, who had received transvenous 7 and 8 French ICD-leads (St. Jude Medical, Riata family) and were followed at our center, formed the basis of this study.
    Results: During a mean follow-up of 42 ± 24 months, 30 of 357 (8%) patients required surgical intervention due to lead failure. For overall lead defects, lead access via the subclavian vein and subpectoral device placement were independent predictors of overall lead failure (OR 3.47, 95% CI 1.38–8.72, P = 0.013 and OR 3.83, 95% CI 1.77–8.27, P = 0.001, respectively). Lead insulation defects at the level of the tricuspid valve accounted for 20% of all lead failures. Diagnosis of this specific insulation defect could only be established by fluoroscopy, while electrical parameters were within normal limits in all of these patients. On univariate but not on multivariate analysis the presence of nonischemic cardiomyopathy was a predictor of this lead complication (OR 8.2, CI 1.5–46.1, P = 0.02).
    Conclusion: Insulation defects of 7 and 8 French ICD leads at the tricuspid level represent an important complication of device therapy. Even moderate changes in lead impedance within the normal limits at follow-up should prompt careful fluoroscopic evaluation to avoid spurious shocks.
    (J Cardiovasc Electrophysiol, Vol. 22, pp. 1018-1022, September 2011)
    DAMIR ERKAPIC M.D.1, GABOR Z. DURAY M.D.1, TAMAS BAUERNFEIND M.D.1, SALVATORE DE ROSA M.D.2, STEFAN H. HOHNLOSER M.D., F.H.R.S.1
    Article first published online: 1 APR 2011
    DOI: 10.1111/j.1540-8167.2011.02055.x
     
  2. Anonymous

    Anonymous Guest

    Lets just say all of upper mgmt on the West coast was well aware of problems with Durata and later Riata....from the Bay area to Sacramento, etc....it is real, whether SJM sweeps it under the rug for their stock price...here's the deal does this company give a damn about patients???? I say not...but it's all about the stock price!!
     
  3. Anonymous

    Anonymous Guest

    Do any of you care about those of us who have these devices? Or just about your income?
     
  4. Anonymous

    Anonymous Guest

    I care. My thoughts to you as a patient is, I'm sorry you had to find out like this. I do regret that you are reading these horrific posts and think this could pertain to your risk of death. The truth is, if you have this lead, you are already deemed a high risk for sudden cardiac death or deadly arrhythmia (the whole reason you have the defib). If you are concerned, I mean really concerned, ask your doctor to look at it. Be adiment. It's your body, your life. You have the right to be proactive and take control of your situation. If he / she refuses, seek help elsewhere.

    I wish you the best.

    not a STJ employee
     
  5. Anonymous

    Anonymous Guest

    I am a patient too. And I LOVE reading the posts here. They are an honest and sobering window into the hearts and minds of CRDM industry. Your callousness and disregard for your own cohorts never ceases to amaze me.

    Now in words you can understand: You are a bunch of pathetic trolls.
     
  6. Anonymous

    Anonymous Guest

    This is no different than any other industry where folks joust....my concern is if this is the only "take away" you get out of this thread is that we fight, then you're missing the point. The common message is to pressure each other to report the truth and name calling is just attention getter's.

    This is a simple stress reliever for a bunch of people who think their stuff is superior than the other but at the end of the day we are commited and driven to improve the QOL of our patients.....aside from our barbs, we all agree with the right thing.....patients first!!!
     
  7. Anonymous

    Anonymous Guest

    Of course I get a lot more out of this board than just the barbs you throw at each other. This is where I learned about those BSC headers that break off the can (which is clearly too thin to properly support a tall CRT header). Or how the Riata's core cuts through its insulation from inside out (and how the Durata Optim insulation is not that much better). Or about that Biotronik Lumax that exploded inside a patients' chest (and the story was quickly and suspiciously pulled from Europace.)

    Those are valuable bits of information my doc would never think to mention. And for that, I thank YOU!
     
  8. Anonymous

    Anonymous Guest

    Oh... PS: You're still a bunch of trolls.
     
  9. Anonymous

    Anonymous Guest

    So true, but you should understand that 99.9% of these trolls are sales reps. They are for the most part overpaid, amoral, greedy m*f*ckrs.
     
  10. Anonymous

    Anonymous Guest

    U know nothing about me. And who are u to say that? I hate stj but not all of their reps are bad people.
     
  11. Anonymous

    Anonymous Guest

     
  12. Anonymous

    Anonymous Guest

    So headers never broke off cans. 4 headers were found loosened sub pectorally. Which division of mdt to u work for?
     
  13. Anonymous

    Anonymous Guest

    Seems to me like SJM is biting off a bit more than they can chew...why is there such ridiculous focus on moving technology forward, when they technology you "already perfected" was never fully certified safe? Dont bother starting a response by saying that the devices WERE certified safe...because we all know the FDA's BS programs (510K and other sleazy-fast review/approval processes) and device companies' "in-house reviews" are all seriously flawed.

    I will stand up in support of a patient who asks an HONEST question like: "Do any of you care about us who have these devices?" Why??? Because I HAVE your devices. Don't grab your balls and tell someone you "feel for them" and you are sorry, but since they are AT RISK FOR CARDIAC FAILURE anyway (since they have one of the leads in question), they should consult their doctor. Isn't that the most common cop out SJM throws out at patients?? You should contact your doctor if your having problems...oh, contact your doctor if you are noticing changes that are uncomfortable...make sure you tell your doctor...blah blah blah.

    If you truly valued patients, you would REPORT adverse events to the FDA. Thats your damn job as a patient rep...and guess what?? If you dont report the event and the FDA finds out that you didn't, the hammer can come down pretty hard. Go ahead, tell me I have no clue what I am talking about. Its not like I volunteered 3 years to SJM NMD to help promote, market, do media pieces, and become a patient ambassador. HEY, I know the damn policies that the FDA handed out to you in the past 3 years regarding adverse event reporting...and trust me, if the world knew what you WERENT reporting, all I can say is WOW. The FDA claims they can stop your manufacturing operations based on violation of this reporting process, but we all know the FDA is in the pockets of the GOP, who are in the pockets of SJM, who are in the pockets of one another...you are all playing pocket pool just pleasuring each other...not giving a @%## about the patients you are slowly disabling or killing because you cant MAN UP and report the problems, knowing that a recall would be imminent.

    I used to be a St Jude Med "success story," I was featured on your website for years...but God forbid that I experience some problems with one of my two SJM implants, right? I didn't know that changed the fact that I was a success story! This company never fails to amaze me...I gave you my TRUST, my BODY, and FULL DISCLOSURE...you gave me SHADY BUSINESS and SECRETIVE recalls/Field Actions, an OCCASIONAL moment of your time (literal moment), and disclosure?? HA!! What a joke. Im blacklisted with SJM NMD...its probably a good thing b/c if the world knew what I DO, if the world knew what SJM did to me, your little Riata problem would be the LEAST of your worries. A 33% compromise of business? Try 100%.
     
  14. Anonymous

    Anonymous Guest

    Quit stewing! You either have a case to sue SJM, or you don't. That is your avenue for recourse.
     
  15. Anonymous

    Anonymous Guest

    Just so you know, I posted the comment to you....first I don't have ball to grab....second, I do feel for you as a patient. I am a patient too. So, do not underestimate the people posting here. We are in the same boat. I have a defib. I am at risk for sudden cardiac death. I have a Riata. I'm a physician........on and on and on. So, the post wasn't to anger you but to embrace you and encourage you.
     



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