Imminent Biotronik Recall?

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Anonymous said:
Use Google Translate on the link above. There was manganese and lithium found on the exterior of the can - that came from the battery, which normally resides inside the can, which means the can did much more than just "expand." And while pocket heating has been reported in the past, nobody has seen cans that expand, spew out battery chemicals in the pocket, and cause 2nd and 3rd degree burns. Give me a break.
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Your going to trust some computer to give you an exact translation of a foreign language? I bet you trust telemetry monitors and think there's no such thing as PEA.....give me a break.
 






finally, some research that will expose big three... and especially so again for Guidant.

http://www.reuters.com/article/idUSTRE70O7IP20110125?pageNumber=1

"Despite the recent improvements made in ICD technology, patients who had their device implanted between May 2004 and 2006 were actually at a greater risk of inappropriate shocks than those who got them earlier."

Connect the dots folks. This was time of the mass Guidant recalls and market share growth by St Jude. Soon enough this study will expose which company's devices were followed and which had the most inappropriate shocks.
 






Anonymous said:
Is the same case r*****!
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Yes, it is the same case...but it is a different article. This one says the issue has known to have occurred 10 times.

I work for either Bio, BSC, SJM or MDT and I can assure you that we have seen this happen more than 5 times and yes, it does include 3rd degree burns and stuff from inside the can gets out into the patient. Which is worse shrapnel or battery acid?
 






Anonymous said:
finally, some research that will expose big three... and especially so again for Guidant.

http://www.reuters.com/article/idUSTRE70O7IP20110125?pageNumber=1

"Despite the recent improvements made in ICD technology, patients who had their device implanted between May 2004 and 2006 were actually at a greater risk of inappropriate shocks than those who got them earlier."

Connect the dots folks. This was time of the mass Guidant recalls and market share growth by St Jude. Soon enough this study will expose which company's devices were followed and which had the most inappropriate shocks.
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So, I guess what you're saying is that inappropriate shocks increased during the period when Guidant devices were not being implanted. Is this because Guidant's rhythm discriminators are superior or do Guidant reps do a better job in getting the discriminators programmed correctly?
 






Anonymous said:
So, I guess what you're saying is that inappropriate shocks increased during the period when Guidant devices were not being implanted. Is this because Guidant's rhythm discriminators are superior or do Guidant reps do a better job in getting the discriminators programmed correctly?
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Don't pay any attention to the man behind the curtain. A BIO device did not explode and the story was not covered up
 






I have been working as an associate professional in the EP/Device world for several years and folks these 'hot cans' are nothing new. Ask Medtronic about the full blown recall that they averted around 2006, I believe. We had people coming in and complaining of 'hot pockets' on a regular basis. We saw several patients with burns from their devices. I think our clinic explanted about 150 devices. No doubt, MDT was proactive in their efforts to cut a massive recall and hysteria off but none the less, this issue is nothing new. GDT or CPI had their own issues with a few devices over the years. Is what is new is the technology that is available to put the pictures out on the internet for the world to see. The pictures were eye opening but it doesn't appear as though the device exploded and blew apart. I listen to reps from 4 of the CRM companies everyday and I am here to tell you that all of you are full of shit. Our EP's know that you are full of shit. They just tolerate your antics because you are a means to an end. Yes, most of our reps are pretty solid technically and have never put our patients in danger but the slander and venom that you spray around is hilarious. I hope none of you live in a glass house because the number of stones that you throw is sad. Seriously, if you guys could only hear the docs call you a creeps and snakes 10 seconds after you leave. I know, I know.... they can call you whatever they want as long as they call you for the implants. I get it.
 












OK, let me correct my previous statement... MDT averted a full blown Class I recall. I have heard that the total nationwide explants on that issue was over 10,000 devices. I know our hospital was taking about 10 a week out. I am not saying they handled it wrongly but it is funny to listen and watch the Big 3 sling all of this mud when they are guilty of marketing and selling their own shitty devices over the years. Speaking about batteries, can someone explain what happens to a SJM device's battery? It seems like the voltage plummets from simply turning them "on".
 






Anonymous said:
OK, let me correct my previous statement... MDT averted a full blown Class I recall. I have heard that the total nationwide explants on that issue was over 10,000 devices. I know our hospital was taking about 10 a week out. I am not saying they handled it wrongly but it is funny to listen and watch the Big 3 sling all of this mud when they are guilty of marketing and selling their own shitty devices over the years. Speaking about batteries, can someone explain what happens to a SJM device's battery? It seems like the voltage plummets from simply turning them "on".
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If you knew about 10 devices failing a week and did not report that it, you were breaking the law. You sir of full of it. There is no way in hell any company hid 10000 failures. Even Biotronik in Slovakia can't bury that many failures, much less here in the USA
 






BSX : Imminent Biotronik Recall?

US Sues Boston Scientific Over Guidant ICDs


January 28, 2011 (Washington, DC) — The US Department of Justice (DoJ)announced yesterday that it is suing Boston Scientific, claiming that its Guidant subsidiary--which it acquired in 2006 --sold implantable cardiac defibrillators (ICDs) that it knew were defective to Medicare between 2002 and 2005 [1].

The DoJ is suing the company by joining a lawsuit filed by a private citizen, James Allen, in Minnesota, under the "whistleblower provisions" of the False Claims Act; Allen says he received one of the defective devices.

The move follows the breakdown of an agreement between Boston Scientific and the DoJlast year, when the US District Courtin Minnesota rejected a proposed plea deal that would have settled the charges against Guidant. That would have required Boston Scientific to pay a penalty of more than $296 million, which would have been the largest criminal penalty ever imposed on a device manufacturer for violating the Food, Drug, and Cosmetic Act.

The allegation is that Guidant knew as early as April 2002 that its Prizm 2 ICD contained a "potentially life-threatening defect" and that it knew as early as November 2003 that other ICDs, the Renewal 1 and 2, contained similar defects. Although it fixed the faults, Guidant continued to sell stock of the old, defective versions of the devices, the suit claims.

"Moreover, as information about the cause and nature of the defect grew within the top ranks of the company, the US contends that Guidant took steps to hide the problem from patients, doctors, and the FDA. Instead of disclosing the problem, Guidant issued a misleading communication to doctors that misinformed them about the nature of the defect," says the DoJ in its statement.

It adds that it was only in May 2005--when Guidant was contacted by a reporter and a front-page story on the subject appeared in theNew York Times--that the company subsequently recalled the devices.

"Patients with serious heart conditions who depend on these devices should not have to second-guess whether they are safe and effective," says Tony West, assistant attorney general for the DoJ's civil division, in the statement. "When a medical-device manufacturer conceals problems with its products, as is alleged here, not only is taxpayer money wasted, but lives are put at risk."

In an e-mail to heartwire , Boston Scientific spokesperson Paul Donovan said: "Guidant plans to respond to the government's allegations and claims for damages in the appropriate fashion."
 












Anonymous said:
If you knew about 10 devices failing a week and did not report that it, you were breaking the law. You sir of full of it. There is no way in hell any company hid 10000 failures. Even Biotronik in Slovakia can't bury that many failures, much less here in the USA
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I never once said or even insinuated that anyone "hid" anything. In fact, MDT brought it all to our attention. Is what I did say is that they averted a full blown Class I recall by proactively handling the situation the way they did. So, no sir... I am not full of it. Please sir, I hope you find the time to come down off of your crystal pedestal and bring me some lunch.
 


















Anonymous said:
Biotronik ICD's are failing in Europe. Any details?
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10 months since the original bullshit post and no recall. You can't recall something that has the highest quality and reliability in the market place. Deal with the fact that the new Biotronik is hear to stay and you will have to compete against them in your markets. If not today then sometime in the not to distant future.
 






Anonymous said:
10 months since the original bullshit post and no recall. You can't recall something that has the highest quality and reliability in the market place. Deal with the fact that the new Biotronik is hear to stay and you will have to compete against them in your markets. If not today then sometime in the not to distant future.
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First off, in case you are unsure, it is here not hear. Second, maybe not a recall from one explosion, but the damage has been done from the journal article already. Third, swarmy ex MDT drunks and sexual harassers do not scare me in my market.
 






Anonymous said:
First off, in case you are unsure, it is here not hear. Second, maybe not a recall from one explosion, but the damage has been done from the journal article already. Third, swarmy ex MDT drunks and sexual harassers do not scare me in my market.
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Smarmy is what most people MEAN when they use swarmy.

Swarmy does appear in the Urban Dictionary, but that only means a preponderance of sorority sisters have been proliferating it.

In brief, swarmy is not a word.
 






Soooooo...... four months later and lets recap. Since the removal no new article. No word what really happened from Berlin. 2 NYtimes front page articles. A new lawsuit today from patients against Biotronik.

Yes the ethics for this company are strong! The typical answer is oh the rest of the industry is no better. Biotronik is mostly the castoffs from the rest of the industry.

The sands of justice grind slow but they grind exceedingly fine.
 


















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