Cognis..... :(

Discussion in 'Boston Scientific' started by Anonymous, Mar 26, 2009 at 12:21 PM.

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  1. Anonymous

    Anonymous Guest


    Let me be first. I left Boston in 2007 after I lost faith.

    Alone - this is no big deal, and I know that every Boston Rep out there wants to believe that. I'm sure that turning this diagnostic off is completely transparent since it probably does not offer any REAL clinically relevant or actionable data. Turn it off - there's no increased risk of inappropriate therapy.

    Let me be CLEAR - this has absolutely NOTHING to do with the rate of occurrence of this advisory ("It's not a recall, doc."), but it has EVERYTHING to do with the rate at which Boston has to release advisories in general.

    But this is not 'alone'. This is going to keep happening. Cognis and Teligen were Boston's opportunity to demonstrate they had a handle on the Quality issue. No one expects any company to be perfect, but BOSTON, what do you have in your bag that has NOT been part of an advisory or recall other than the leads Biotronik sells you?!?!?

    There was another thread on CP where a Boston Rep suggested that talking about recalls was "...so last year." Enough said.

    The larger issue is that this muddy's the waters for ALL of us.

    You guys have got THE GOLD STANDARD for LV lead delivery systems.
    You guys have a good pacemaker in the Insignia.
    I think the programmer is awesome.
    Cognus and Teligen may still prove to be great devices, but they do not offer a physician the one key differentiator they are meritably looking for: not part of the continuing Boston legacy of quality concerns (big or small).

    That being said - I think the fact that you STILL have the market share you do is indicative of HOW HARD it is for a physician to admit he was wrong by bailing on a company. How hard it is to admit he isn't addicted to the payola. Exposing your patients to the QOL that comes with "We need you to come in so we can fix something in your device" or "Nevermind those newspaper articles..." - is not right.

    If you do 80% business with one company - you deserve this. If you sign a 90% "lockout" contract - you can't complain. Competition is good medicine: prices go down, quality goes up.
     
  2. Anonymous

    Anonymous Guest

    Spoken like a small share rep.
    First, this advisory doesnt muddy any water. I think docs are fully aware that the Fidelis timebombs are PE#1 right now. Mix in some 2-3 year STJ cans and this thing is minor. No, really. FYI, lead fractures usually cause a shock anyhow. This is just a minor incremental increase in the chance of oversense when the lead cracks. Which inappropriate shocks usually happen with any can on a cracked lead. Also, it was discovered on another lead <cough fidelis cough>. (There was some great share mix). Docs are using BSC because it is a great system. 1. No ICD lead questions (i.e. like Perferata or Fidelis) 2. Full featured small cans 3. #1 LDS for CRT. 4. No compromise on technology when using BSC.
    If you want to use STJ or MDT, fine. But a doc doesnt have to make ANY excuse to use BSC now. No one wants to hear that, but its true.
    Now I will agree BSC is being run by clowns. Please let there be a buyout!!!!!!
     
  3. Anonymous

    Anonymous Guest

    I was never big on math, but how is there a "great share mix" of Fidelis on devices that were introduced a year after Fidelis was pulled off the market?
     
  4. Anonymous

    Anonymous Guest

    When Cognis and Teligen came out, were you hopeful that they represented Boston's new era in quality?

    So was everyone else...

    When I worked for Guidant / Boston - we started off the recall surge by emphasizing 'manufacturing errors' and how they were inherent to ALL devices. After 13+ advisories and recalls, this became the punchline to an inside joke.

    As I left, I was chastised that the new products were coming and I was leaving at the wrong time.

    So, a few months later - these devices came out and IMMEDIATELY they were implicated in uncontrollably shocking patients during DFT's in Arkansas and the Houston VA.

    These were folded into the "software fix" meant to address a separate and distinct telemetry problem some clinics were experiencing during routine follow-ups.

    So, fast forward to this latest thing with Cognis and Teligen.

    I gave you the compliments above: nice pacer, great LDS...

    But you are deluded if you claim any accolades for quality. As long as you sell another company's lead (Dextros) and depend on Promus to prop up the VI side, I expect your tone should be one of "wait and see", because your tone in the above response rings hollow in the face of your company's continuing trend of "oh-by-the-ways"...
     
  5. Anonymous

    Anonymous Guest

    I guess the point I was trying to make is that we are all a little sick of former BSC/GDT people and other comp reps pointing their fingers and saying "See, BSC has poor quality" as you sit in your very thin glass houses. Get a grip. You wanna point out N=2 VA or Ark like it was the FIRST EVER device problem... ever. Who said C/T was perfect? Who said ANY device is perfect? But face it, MDT spends a good bit of their day extracting leads or running to ER's to shut off cans who are shocking wildly. Meanwhile, STJ reps are trying to explain that post op perf or why their can lasted months not years.

    You left BSC. Good for you. Dont blame your woes on us and figure out the grass is no greener where you ended up.
     
  6. Anonymous

    Anonymous Guest



    Face it, BSC is a joke and a stain on the industry. Sure the other companies have issues, but the smug attitude BSC has while delivering letter after letter is what everybody is so sick of. Also, I don't think anyone thinks the Houston VA or Ark problems are the first ever device issues, but they are 2 more issues from a company that keeps saying everything is good, we fixed the problems, etc, etc. No one wants this attention for the industry, none of the companies will benefit from it.
     
  7. Anonymous

    Anonymous Guest

    Smug? Who delivered a letter that way? You? Maybe some did but face it this industry is full of assholes. You know it. That is assholes for all companies.

    See, your post says it all. Everyone blames BSC/GDT. Why? Excuses! Look at some history and the facts. Look at failure rates. No one has placed more of a blight than another. You just had it made in April 05 and hated what hit you in May. Good luck doing whatever you do, because the world is full of crap stuff ya gotta do. My guess is that the next 18-24 months will be filled with Fidelis talk and the "2005" stuff will seem like another step in the evolution of this very difficult business.
     
  8. Anonymous

    Anonymous Guest

    As of end of May, the events have jumped to more than 500 each for Cognis and Teligen on FDA MAUDE. Anything happening on these devices?
     
  9. Anonymous

    Anonymous Guest

    Most look like Malfunctions of some sort. Not the usual mix of Infections often seen on MAUDE. Poor guys! Been a rough few years. Wonder when this shoe will finally drop
     
  10. Anonymous

    Anonymous Guest

    listen assholes. BSX released the cognis teligen devices with full knowledge of a faulty header, software latching issues, and an MV sensor that could kill people by inducing the pt. Not to mention your shitty impedance measurement design. 36000 released, 8000 affected, hmmmm aurora, 300 engineers, 600 million spent for what? more recalls and faulty devices, your shit is flawed at a systemic level. Good luck and please hit 15$ a share before your company is chopped up into pieces. Daddy needs a new boat.
     
  11. Anonymous

    Anonymous Guest

    The March 2009 advisory letter concentrated on some sort of software issue, but people here were talking about the faulty header, seals, set screws problems which were resulting into unreliable electrical connections leading to inappropriate shocks and failure to provide required therapies. Anyone here know the real issues?

    MAUDE had few hundred MDRs but FDA seems to have reduced the numbers to only around 30 or so for both Cognis and Teligen. Almost all of these have resulted into patient deaths.

    Hope the lead connection issues have been resolved so that there will not be any more problems of inappropriate therapies in the future.
     
  12. Anonymous

    Anonymous Guest

    Just wondering, after FDA Class II recall of Cognis and Teligen, how BSX is handling these devices? Any corrective/preventative actions taken to save patients?
     
  13. Anonymous

    Anonymous Guest

    To all of you out there who think their stuff does not have issues, think again. Nobody is perfect!!! A lab can only replicate real world activity. MDT ( Concerto & Fidelis), STJ (Atlas longevity & Riata), Boston Sci ( Resp sensor & Prizm), Biotronik ( Belos & paying off culture). As an industry we should hope that we all correct our problems!! When one of us does bad it hurts all our sales and patients. If Mercedes, Bmw, Lexus, Toyota have issues why not us!! We all need to clean up our acts and produce the best products possible for our patients......
     
  14. Anonymous

    Anonymous Guest

    Payoffs! The comapnay(BSX) that is currently under a full DOJ investigation for its training program has the gaul to discuss payoffs! Boston Scientific has has 20 recalls in the last 3 years.

    You all suck and your company is a joke!
     
  15. Anonymous

    Anonymous Guest

    Don't work for BSC. It's funny how Biotronik trolls get so defensive when you mention payoffs.......sorry, registry...
     
  16. Anonymous

    Anonymous Guest

    Sure you work for BSX you pole smoker...training, registry, speaking agreements. Your company does them all.
     
  17. Anonymous

    Anonymous Guest

    I am not defensive about payoffs. I am defensive about the implication that we're alone in the payoffs business. It's hilarious that you feel so confident that some of your business is not predicated on just this type of practice.

    To poke fun at myself, it's obvious that our "kickback program" isn't working since we only command 3-4% of the US Market.

    I guess we need to take a look at how well you guys are doing yours since you're able to buy your way out of accountability for: "Perf"-ata, Fidelis and [Insert Boston Product Name Here].

    MEDTRONIC
    "Medtronic has been under scrutiny for its payments to physicians since 2006 when it entered into a $40 million settlement to resolve allegations it paid kickbacks to physicians."

    http://blogs.hcpro.com/epharmaceuticals/2009/02/medtronic-to-disclose-payments-for-physicians/


    BOSTON SCIENTIFIC

    "The suits, originally filed in 2007 but recently unsealed by a Texas federal judge, allege that a "fraudulent marketing and inducement campaign" involving kickbacks to doctors and hospitals resulted in excessive charges to the Medicare insurance program."

    http://nasdaq-atrc.blogspot.com/2009/07/medical-device-suits-allege-kickbacks.html

    ST. JUDE

    "St. Jude Medical said Thursday U.S. regulators are probing the heart device maker for allegedly giving kickbacks to the Iraqi government in exchange for sales of its products."

    http://www.redherring.com/Home/16149


    Plainly stated: to imply any ONE company is any LESS guilty of this laughable.
     
  18. Anonymous

    Anonymous Guest

    Why stop giving kickbacks? The DOJ has been ...........(Working) on this for years. All the while these compnies have made billions with these payoffs.

    IF and maybe when the goverment steps in the device companies will be a slap on the hand in comparison to all the damage that has been done to the tax payers.

    Come on everyone knows that a device rep is the 21st century Al Capone minus the good suits.
     
  19. Anonymous

    Anonymous Guest

    What sorts of payoff practices have been followed in European Union countries? Looking at how European Union twisted Microsoft's arm for certain business practices, are there any modified kick-back practices exist for European Union? However, all over the world the human beings are same and we all have our price.

    It appears fairly easy to obtain market approvals for medical devices in Europe. No FDA there and all certifying bodies are private organisations. Almost all device approvals for US firms usually first start in Europe and then after a year or two later FDA approvals follow.

    Any thoughts?