Imminent Biotronik Recall?

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The problem stems from the lithium battery in this device. There are many implantable devices which use a lithium battery and they ALL have this problem. Biotronik is LUCKY the seam weld on the can held fast and the battery acid did not leak out into the patient. Other patients have NOT been so lucky!

Can anyone recommend a battery quality control expert that we can utilise as a resource to eliminate the risk of this happening again? We know our competitors struggle with this issue. If we solve it, it will be a significant competitive strength. Please advise.
 






Anonymous said:
The problem stems from the lithium battery in this device. There are many implantable devices which use a lithium battery and they ALL have this problem. Biotronik is LUCKY the seam weld on the can held fast and the battery acid did not leak out into the patient. Other patients have NOT been so lucky!

Can anyone recommend a battery quality control expert that we can utilise as a resource to eliminate the risk of this happening again? We know our competitors struggle with this issue. If we solve it, it will be a significant competitive strength. Please advise.
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Bizarre.
 












Anonymous said:
The problem stems from the lithium battery in this device. There are many implantable devices which use a lithium battery and they ALL have this problem. Biotronik is LUCKY the seam weld on the can held fast and the battery acid did not leak out into the patient. Other patients have NOT been so lucky!

Can anyone recommend a battery quality control expert that we can utilise as a resource to eliminate the risk of this happening again? We know our competitors struggle with this issue. If we solve it, it will be a significant competitive strength. Please advise.
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Yes, this really happens everyday. Review these pictures and I'm sure you'll agree that CRM reps see this all the time.

Photos:
http://www.medtees.com/blog/ICDBoom1.jpg
http://www.medtees.com/blog/ICDBoom2.jpg
 






Anonymous said:
In all of these posts, we agree its ONE confirmed case?

Are we quibbling over one or something else?

If we're quibbling over the presumed Worldwide conspiracy between Biotronik and their few loyal implanters to cover up the thousands that are exploding around the world, then we can open up theoretical attacks on the exponentially larger threat posed by the THOUSANDS of POSSIBLE undiagnosed Riatta and and Fidelis issues, and the HUNDRED of THOUSANDS Boston <Insert Any Device Name Here> issues.

So, if we're quibbling over our ONE confirmed can, then I'll stand by that record. Tell your customers about our ONE, and then be prepared to explain to them why you even seem concerned about the once unheard of Biotronik.

If Obamacare leads to the light of day being shed on this industry as we moved forward in to socialized care, pray that your lobbyists spend the next 3 years lining the right pockets. Side-by-side, no public official in their right mind would endorse a nickel going to some of these companies, unless they were receiving a dime on the backside.
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I do not agree it is just ONE as you say. We would never have heard of this one unless this doctor published the case study. You were being underhanded and denying that this even happened a few months ago. If you can hide one, how many more are being hidden? The answer to that is unknown. Do not try to deflect to the other companies saying oh lets see what they are hiding. Focus on your own and what they are hiding, because it is easier for them to do so than the American companies.

Oh and by the way, I don't worry about Biotronik, and I don't need to explain anything to my doctors. They are smart enough to see through the company's facade without any prompting from me.
 






The FDA needs to require MDR's and trending for pocket heating. That would help everyone to understand the real #'s. YES this happens hundreds of times per year at each company with more than a couple of thousand devices on the market.

The issue is real and needs to be resolves ASAP
 






Anonymous said:
If you can hide one, how many more are being hidden?
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Anonymous said:
Do not try to deflect to the other companies saying oh lets see what they are hiding.
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Hey, hypocrit. Really? Geez! Clearly you work for one of the 'other' companies, yet you are attempting to bash this one by claiming they are doing exactly what your company does and has always done. You are a moron! Maybe your docs should worry about you. Idiot.
 






Anonymous said:
The FDA needs to require MDR's and trending for pocket heating. That would help everyone to understand the real #'s. YES this happens hundreds of times per year at each company with more than a couple of thousand devices on the market.

The issue is real and needs to be resolves ASAP
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I have been in this business 25 years, worked for 4 CRM companies and have never seen or heard of this issue. How have you come to understand the "real #'s"? I am certain the OIG would like to see your evidence. Can you share the FACTS with us?

Also, if your company educated you properly regarding the MDR process, you would understand that an issue such as this must be reported; thus, in addition to your "real #'s" perhaps you can shed some light on the massive conspiracy of industry reps, executives, allied health personnel, and doctors who are covering up all these incidents.
 






Anonymous said:
I do not agree it is just ONE as you say. We would never have heard of this one unless this doctor published the case study. You were being underhanded and denying that this even happened a few months ago. If you can hide one, how many more are being hidden? The answer to that is unknown. Do not try to deflect to the other companies saying oh lets see what they are hiding. Focus on your own and what they are hiding, because it is easier for them to do so than the American companies.

Oh and by the way, I don't worry about Biotronik, and I don't need to explain anything to my doctors. They are smart enough to see through the company's facade without any prompting from me.
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I wrote the post you've taken issue with, and I didn't say that we agree that's its just one - I said that we've all agreed that its just one CONFIRMED case.

I agree on your point that the unknown is the unknown. It's hard to debate the unknown. So let's just stick to what we have evidence of....our one confirmed can versus what you have confirmed from your MDT / BSX / STJ recalls.

That's fair, right?
 






Was it fair that you tried to cover up the one? Even with Watergate the issue became the cover up. Kaboom! So now that it has been exposed instead of being able to say , no problem here, you say it was only one. But lies are lies are lies.
 






Cover up?
You, working for BSX/MDT/STJ, are actually trying to assess blame on another company for a cover up!? First, there is no claim, accusation, or evidence thay any cover up existing.
Secondly, and again; hey hypocrit, you are an idiot!
Fool.
 












Anonymous said:
I have been in this business 25 years, worked for 4 CRM companies and have never seen or heard of this issue. How have you come to understand the "real #'s"? I am certain the OIG would like to see your evidence. Can you share the FACTS with us?

Also, if your company educated you properly regarding the MDR process, you would understand that an issue such as this must be reported; thus, in addition to your "real #'s" perhaps you can shed some light on the massive conspiracy of industry reps, executives, allied health personnel, and doctors who are covering up all these incidents.
Click to expand...

Just to update you on the MDR process, it needs improvement. Here's why not all of these types of incidents are reported as MDRs: (1) not all pocket heating incidents result in an explant; (2) some explants are reported as "relacements"; (3) coding on the MDR form is different for medical device companies--they don't include the "patient code" (which would likely capture the pocket heating" affect on the patient); (4) many companies only report incidents that they consider to have actually caused significant harm to a patient (and pocket heating may be considered minor discomfort in many cases); and (5) if the device is marketed OUS only (outside the United States), then a report is not done to the FDA.

Last time I checked the Maude database, it looked like the FDA was more than a year behind in some areas for updating the database with data!!
 


















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