Imminent Biotronik Recall?

Does anyone out there know how to get ahold of the case study? Was it actually published in print in Europace?

 

It was removed a day or two after it was published to the website. There is a poster above who will email it to you. If you don't have a copy now what is your interest?

 

This whole episode is starting to appear all around the web at various blog sites. It appears the blogging world is coming to the defense of Dr. Fisher who was forced to remove his blog after Bioreonic had the original case study removed by Europace. Maybe they can shut down the Internet the keep the story from spreading.

 

Let's start back in 1988. Cordis had a group of people that were there and they were acquired by Telectronics. Cordis had an issue of filing false reports with the FDA.

http://www.nytimes.com/1988/09/01/us/manufacturer-admits-defects-in-pacemakers.html

Cordis was acquired as well as some of the people to become part of Telectronics. As of today there are remnants of a company called Telectronics still left within Biotronik's walls. Yes St. Jude bought the technology but many of the people from Telectronics made their way to Biotronik and a few still remain. The same man ran Tele in the USA ran Biotronik for 10 years and just stepped down. As we all recall Tele had a problem with their atrial J lead. They were forced to recall and shut down manufacturing due to paperwork issues and under or non reporting of the problem. Meaning they did not file MDR's and even were found not to return some of the devices.

http://www.thefreelibrary.com/Complaint,+MDR+concerns+preceded+TPS+consent+decree-a083057710

Now let's move on to 2005. One of the early advisories, regarding Guidant’s PRIZM 2 DR ICD (Guidant Corporation, USA), was issued by Guidant and the United States Food and Drug Administration (FDA) only after The New York Times broke a story about a young, American patient with hypertrophic cardiomyopathy who died when his ICD failed to rescue him from sudden cardiac death. It was determined that the device had failed, and furthermore, that the defect was a problem that was occurring systematically, although only in a very small percentage of all manufactured devices. It subsequently became clear that the problem had first been detected three years earlier (in 2002), and while Guidant Corporation apparently fulfilled all of their legal obligations to notify the regulatory agencies, they elected not to notify patients or doctors directly about this until The New York Times article was going to press.

I have seen other posts calling the behavior of the leadership at Guidant deceitful. Whether they were or not, could be debated I suppose. Let us now turn to 2010.

Many of the people from Guidant in 2005 have left. Where did some of them find a home? Biotronik has landed some of these reps and senior management within it's walls.

There is your lesson in history. My mom always told me your reputation is all you have, knowing the history and following it through to today doesn't make me want to follow leaders blind anymore.

What are they hiding???

 

There is a small group of executives who went from Cordis to Telectronics to Biotronik. I'm sure the business plan didn't change much from company to company.

 

There is a small group of executives who went from Cordis to Telectronics to Biotronik. I'm sure the business plan didn't change much from company to company.

 

FYI to these previous posts:

Europace report published inaccurate information. Also the Author has since voluntarily requested the article be removed since it contained so many errors on the alleged "battery explosion."

Europace has responded by pulling this study from its website on October 6th.

Do your due diligence and maybe you will spend more time in the Lab then in online opinions and rumors.

 

If that is not the most "grasping at straws" tie in I don't know what is. The fact that the same players are not involved with the 3 companies mentioned above is without dispute.
Better than that is that somehow you want to intimate that the USA sales team has the ability to have a European Physician voluntarily remove His hyped up story out of Europace! The whole incident has been blown way out of proportion to say the least.
If your physicians don't use Biotronik this won’t make them use you anymore and If they use Biotronik they already know that this story is bullshit and It will not change their minds about the company.

My guess is we are hiding pictures of your Mom and the donkey she use to do 3 shows a day in Tijuana before your were conceived and she lost the work.

 

Please use the mom defense when the FDA is investigating your MDR process, I am sure it will work well for you. As far as the US Sales team reaching out to Dr. Hudec, I am sure your right, that it didn't happen, but I am fairly certain that Berlin did. As far as grasping at straws, the facts remain the same some of your current and almost all of the previous executive regime worked for Cordis and Telectronics prior to arriving here. The FDA found them to be lacking in their MDR process, you should hope that they do not find Biotronik to be as well. We all know what happened to them both. The FDA shut down BSX earlier this year for a "paperwork issue" The FDA doesn't take to kindly to cover ups and nonreporting.

 

http://thehappyhospitalist.blogspot.com/2010/10/disappearing-or-censored-reporting-of.html

Take the poll? See if you are one of the 96% who believe Biotronik forced Dr. Hudec to take down his report out of Europace.

 

I bet you the patient wasn't too pleased with the results, not too pleased at all.

Sincerely,

Flame Boy

 

I welcome the chance to have a conversation with the FDA. I know it will be my first time and clearly you have plenty of experience in dealing with your own FDA issues. My guess is that they will believe the facts.

This is an isolated issue that other CRM companies have experienced. That's it end of story..continue to flame away it will not get traction.

 

Fact - Catastrophic Malfunction of device

Fact - Widely Publicized event

Fact - Your shitting in your drawers hoping for this all to go away and it is just getting started

 

The Maude database for Lumax since the first of the year shows quite a few early depletions and short circuits. What's up with those?

 

I talked to a Biotronik rep today and he said that everyone makes their batteries the same way. Does anyone have knowledge of what Biotronik communicated with their reps? It sounds like they are trying to lump this event in with all ICDs sold by all vendors since it was a Wilson Greatbatch Battery. He assured me that this is a one time only event and it could have happened to any company at any time. Is this true? I read through the thread in these pages and it sounds like a lot of Biotronik people vs a lot of anti-Biotronik people trying to make each other feel crummy. Imagine if a device patient were to happen to read the posts here. Quite shameful. I do feel sorry for a lot of people in here because of the motivation. Are we really happy that a company's reputation is damaged and a patient is injured? I'm not a fan of Bio, but I can honestly say it is tragic that this happened. This wont be the last time, either. A lot of patients have felt the same sensation that is in line with this event. They best drop the hubris and call it what it is. Advisory. We can all start to move forward. But it wont happen that way, the same way it happened the last time Bio had a recall. Anyone out there know how many patient injuries or deaths were caused in the Belos/ Tachos recalls? I do.

 

http://www.medtees.com/content/Europace%20Article%20QA.pdf

That is the official internal memo

 

What happened with Belos Tachos? They told us it was the same problem everyone else had and that it was a very small amount of patients

 

This answers all your conspiracy theories quite well. Best of luck with your physicians and trying to make this something it's not.

 

Yes everything is done here. There is nothing to see. Just move along.

 

Bye Jake.

I pitty the fool that has to take over this mess of an organization. The house of cards is set and there's a couple very stiff breezes coming from FDA and our friends in the government.

Aloha Mr Hand