Cognis..... :(

Quote
Anonymous said:
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.
Click to expand...


After nearly 14 months of your post, it looks like it was a spot on prediction!
 




































Anonymous said:
A new and robust header (Mark 10) is undergoing validation, it may take a month or two to get PMA (Suppliment) approval from FDA. We all can hope thjat the sales of C/T will skyrocket.
Click to expand...

Hahahahahahaha, skyrocket, what a joke.


"Dr X, let me tell you about our new header. No, it's not attached to a new device, it's just a new header. No, not the replacement header, this is the replacement for the replacement. No, the device is almost 2 years old. Yes, it's very different, and way better than anything else on the market. How is it better? Well if you'll shut the fuck up for 2 seconds and let me finish, I'll tell you. I know you're used to just hearing about recalls and advisories from me, but this is different and I can't just leave the letter and go. I need to tell you about it, so shut the fuck up and listen."

Make sure you fill the paperwork out completely this time, you fucking idiots. So glad I left when I had the chance.
 












Yeah we are still selling them. We sell them because it's all we can sell. Our hope is for a new device to be approved to sell when we can no longer sell these. Every day I pray this isn't the one that Cognis is pulled from the market.
 






Anonymous said:
Yeah we are still selling them. We sell them because it's all we can sell. Our hope is for a new device to be approved to sell when we can no longer sell these. Every day I pray this isn't the one that Cognis is pulled from the market.
Click to expand...

In the absence of any firm and constructive action on the part of BSX top management, I think that the end of C/T cans is approaching fast, Class I recall with FDA warning letter to stop manufacture of these killers might be on the way soon.
 






Anonymous said:
In the absence of any firm and constructive action on the part of BSX top management, I think that the end of C/T cans is approaching fast, Class I recall with FDA warning letter to stop manufacture of these killers might be on the way soon.
Click to expand...

What you think is irrelevant. The FDA isn't going to do anything.
 






Anonymous said:
What you think is irrelevant. The FDA isn't going to do anything.
Click to expand...

Have you managed Payola to safeguard C/T cans?
I respect FDA staff b/c they are incorruptible so they will never ever turn a blind eye on these killer cans.
I feel that Class I recall coupled with manufacturing/shipping halt with a strong warning letter are on the way.
 






Anonymous said:
Have you managed Payola to safeguard C/T cans?
I respect FDA staff b/c they are incorruptible so they will never ever turn a blind eye on these killer cans.
I feel that Class I recall coupled with manufacturing/shipping halt with a strong warning letter are on the way.
Click to expand...

Based on what? "I feel" is a pussy comment, give us something to back it up.
 


















Thank you.They refuse to accept reality because they're internal of BSX,most probably CRM division,namely Hybrids.As I said,let them try to explain to the late Joshua's(God rest his soul.)parents just how good their cans are.Shame on BSX,a company without conscience!
 






Anonymous said:
Thank you.They refuse to accept reality because they're internal of BSX,most probably CRM division,namely Hybrids.
Click to expand...

Hybrids are very complex microelectronic parts to understand as they are usually designed and manufactured by a specialist firm.

Let us talk about very simple parts everyone understand - like set screws, seals, header and associated hardware, selection of appropriate glue to assemble header and titanium can. These are very simple parts to design, manufacture and effectively inspect to ensure that the design philosophy has been met. In the past, Guidant/BSX have effectively used these parts without any problems.

Right from the day one of market release of C/T cans the problems have been in set screws, bleeding headers, header detaching from can and leads refuse to stay in their ports resulting in failure to provide therapy. That is very simple to understand is it not?

It is unfortunate that BSX failed to fix these issues and went on selling these killers. As an icing on the cake, it appears that the BSX quietly replaced all old headers; this involve lots of rework - including desoldering hybrids and other mechanical/electrical parts then resoldering it back.

The debacle continued and BSX did not learn any lessons from their own mistakes and other's mistakes!

How long the FDA is going to silently watch this?
 






"How long the FDA is going to silently watch this?"

Forever.

I mean, if the FDA has not been moved to act by now, what MORE can BSX do?

Moreover, is a government organization going to put a business to the sword adding more folks to the ranks of the unemployed during times like these? Don't talk to me about the FDA's mandate to protect the American people, that ship sailed 15 recalls ago.

No, Boston is here to stay. I've said it many times on this board: if a doctor is STILL implanting Boston at this point, there is only one thing that can happen that will cause them to stop: the payola dries up. Otherwise, no rational self respecting hypocratic oath honoring implanter can convince me on Boston - particularly when so many viable device options are out there.
 


















Top Bottom
Back
Quote