Imminent Biotronik Recall?

Discussion in 'Biotronik' started by Anonymous, May 24, 2010 at 2:09 PM.

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  1. Anonymous

    Anonymous Guest

    You have your facts wrong.

    The two RSD's that you are talking about are in charge of the Southwest and Pacific Northwest areas. More about not needing these people anymore (Biotronik let go of 5 RSD's total) than what you are trying to imply. Keep spreading the rumors and those areas will just keep beating the shit out of you on the playing field.

    Good Luck
     

  2. Anonymous

    Anonymous Guest

    That's a bunch of spin. Mighty big coincidence. Time will tell
     
  3. Anonymous

    Anonymous Guest

    You sir have your facts wrong. 5 weren't let go. 4 were and one took a "sales job". Bio had no choice. They had to fire someone to create an appearance of compliance once they were backed into a corner. One was necessary, the other was spite. What is true is that they clearly didn't fire the offenders, but the messenger and the crony. Bio historically keeps anyone who drives and grows business. Managers walk the line of helping to create an environment for their type of business to flourish and keeping it under control. As goes with their title, managers will take the fall, unless they can drive more business than the offenders do. And to the opinion that they weren't needed, their credit cards were the reason they were needed as well as creating an army of retained consultants, trainers and speakers for what is still up for debate. I dont think they're beating the shit out of many, just sweeping market share proportional to whom they've recruited. Those who do go over realize they either better be cashing out at the end of a good career or swing for the fence. The reputation which may have been hard earned is now slightly stained by greed and filth.
     
  4. Anonymous

    Anonymous Guest

    You're insinuating that what is said of Bio are rumors. Credit card receipts, consulting contracts, study documents etc compared to sales numbers are a a bit more tangible that here-say.
     
  5. Anonymous

    Anonymous Guest

    Dont know about Europe, but the cans seem to do well in the US. 3 years on the current generation and no issues. Last generation was the same. Some results can be washed but only for so long(fidelis).
     
  6. Anonymous

    Anonymous Guest

    Why don't you all go back to the Boston Scientific board and bash the shitty and unethical company that you are stuck working for, or the St. Jude board were you just paid another fine to the DOJ and continue to pretend that you didn't, or Medtronic which has the worst reliability of any company ever...

    Let the regulatory companies investigate everyone and lets just see what happens. Biotronik is not going away so get ready to deal with 4 vendors on the your next contract!
     
  7. Anonymous

    Anonymous Guest

    WAAAAAAAAAAH!!!!!!!!!!!

    Leave us alone. We don't like the truth.
     
  8. Anonymous

    Anonymous Guest

    The truth? Who can even know what that is anymore, much less think that it would be anywhere on this board?
     
  9. Anonymous

    Anonymous Guest

  10. Anonymous

    Anonymous Guest

    better yet... see for yourself

    Dňa 12.05.2010 o 21.50 ŠÚKL dostal úvodné hlásenie od nemeckého výrobcu defibrilátora, spoločnosti Biotronik SE & Co. KG. Hlásenie sa týkalo zlyhania aktívnej implantovateľnej zdravotníckej pomôcky - defibrilátora typu Lumax 340 VR-T, výrobné číslo 60480372, ktorá sa stala v SR.
    Výrobca v hlásení a následne aj ošetrujúci lekár uvádzajú, že po 1 mesiaci od implantácie defibrilátora vzniklo náhle poškodenie prístroja sprevádzané zvukovým efektom a malo charakter explózie, čo spôsobilo poranenie hrudníka pacienta. Pacient má lokálne komplikácie - popálenie kože v oblasti pôvodného umiestnenia prístroja, vzduch v podkoží a okolitých mäkkých tkanivách. Defibrilátor bol pacientovi explantovaný v Stredoslovenskom ústave srdcových a cievnych chorôb, a.s. (SÚSCCH a.s.) v deň zlyhania. Pri vizuálnej kontrole explantovaného prístroja bolo nájdené mechanické poškodenie - zväčšenie objemu a zmena tvaru prístroja, pričom vonkajšia makroskopická porucha integrity nebola zistená. Podľa výrobcu doteraz neboli hlásené žiadne podobné udalosti. Výrobca o nehode dobrovoľne informoval notifikovanú osobu NB 0123, TÜV SÜD Product Service GmbH.
    Dňa 14.5.2010 predstavitelia výrobcu odobrali na mieste poškodený defibrilátor, ktorý bude podrobený analýze vo výrobnom závode v Nemecku. Výrobca na základe výsledkov analýzy prijme ďalšie nápravné opatrenia.
    Pacient je v súčasnosti hospitalizovaný v Banskej Bystrici v SÚSCCH a.s. a je mimo ohrozenia života.
    ŠÚKL analyzuje vzniknutú situáciu, spolupracuje so zdravotníckymi pracovníkmi SÚSCCH a.s., výrobcom a distribútorom v SR.
    Do času, kedy budú známe výsledky analýzy zlyhania defibrilátora, ŠÚKL požiadal distribútora v SR o dočasné pozastavenie uvádzania defibrilátora na trh.







    On 05/12/2010 21:50 SIDC received the initial report from a German manufacturer of defibrillators, the company Biotronik SE & Co.. KG. Report involved a failure of active implantable medical device - a type of defibrillator Lumax 340 VR-T, serial number 60480372, which has become in the. Manufacturer in the report and, subsequently, the treating physician indicates that after a month after defibrillator implantation was accompanied by a sudden damage to the device audio effect and had the characteristics of the explosion, which caused injury to the patient's chest. The patient has local complications - skin burn in the original location of the device, the air under the skin and surrounding soft tissue. Explantovaný defibrillator patient was in the center of Institute of Cardiovascular Disease, and (as SÚSCCH) on failure. The visual inspection explantovaného device was found mechanical damage - increase the volume and change the shape of the device, the external integrity of the macroscopic failure was detected. According to the manufacturer so far been no reports of similar events. The manufacturer voluntarily informed about the incident NB notified body 0123, TÜV SÜD Product Service GmbH. On 14/05/2010 manufacturer's representatives were taken on-site defibrillator is damaged, which will be analyzed at the factory in Germany. Producer on the results of the analysis will take additional corrective measures. The patient is currently hospitalized in Banska Bystrica and SÚSCCH in and out of danger to life. SIDC analyze the situation, working with healthcare professionals and SÚSCCH, manufacturer and distributor in Slovakia. Until such time as results are known defibrillator failure analysis, called a distributor in the SIDC SR to suspend marketing of the defibrillator market.
     
  11. Anonymous

    Anonymous Guest

    The device did not explode. The patient felt it heat up and at no time did the device fail or not deliver therapy. The device was explanted and replace with a new ICD. Patient and Physician are both pleased with results.

    Once again you loose "Flame Boy"
     
  12. Anonymous

    Anonymous Guest

    Link please? I see nothing regarding your claims.
     
  13. Anonymous

    Anonymous Guest

    oh really?? prove him wrong then. Looks like you knew about it all along...didn't cha? Were you also instructed what to say about it? ...reading your reply sounded like Bush's speeches..all coming through his ear piece! I bet you've said it like 1000 times since then..
    crawl back into your cave dude, either accept the facts or if you chose to lie about it and act as it never happened then simply stick to it. Liar.
     
  14. Anonymous

    Anonymous Guest

    Above is my original post. So, fu to all of you lying Nazis who said I was full of Sh*t.
     
  15. Anonymous

    Anonymous Guest


    You are full of shit you BSX stooge! The entire letter that you were informed of was written by the BSX Distributors country manager in Slovakia. Their has never been an official communication about this from the government.
    Biotronik inspected the ICD and it was found to have a random component failure. No patient injury or adverse events occurred. The device was replaced and patient is doing fine.
    Now if you don't believe me call the BSX Country Manager in Slovakia his name is
    Mr. Pavel Bohdal. He is the Country Manager of the Boston Scientific distributorship in Slovakia!
    You should also note that BSX reps in the US were informed to cease and desist in using this "marketing" approach due to slanderous and baseless accusations.
     
  16. Anonymous

    Anonymous Guest

    Who is on that website? Looks like the government to me. It is a hoax?
     
  17. Anonymous

    Anonymous Guest

    www.sukl.sk

    Government site, so the government let's a BSX distributor post on the site? I don't think they are that crooked, even in Slovakia. Maybe Germany, but not Slovakia.
     
  18. Anonymous

    Anonymous Guest

    All recalls begin with "random component failures". I'm a BSCI rep and learned about this failure on this board. I have not seen a cease and desist order. Just keep denying and covering up your issues. I'm sure it will work out for you.
     
  19. Anonymous

    Anonymous Guest

    You are a mouthy looser. Why don't you call your lead council Dan Gerhan and get bitch slapped if and when you are caught spreading lies.