Cognis..... :(

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!!!!!!

Sir or madame, you are a flippin' idiot. 1) Continue to use your drinking straw sized RV ICD lead which does a great job at delivering all of those inappropriate shocks from your frisbee sized ICD. 2) Turn off some of the features if you want the can to operate...but let's not forget that the header may fall off, can you shut that feature off too? And don't give me that bullshit about sub pec implants, the same forces occur sub q so it may take a bit longer to manifest itself...but it will 3) Okay, I will give you that one, the SJM system does well but Guidant had a good system first so why change? and 4) This one is laughable like another person said the only thing in your bag that does not have a recall or an advisory attached to it is the Biotronik lead and the biotronik analyzer. Can't wait for the website to see which doctors were on the take...but I bet the website will be recalled too. I do like your pens though!!
 






























BSX has already solved this problem.

Unless something else shows up in the field, there will not be any recalls of Cognis and Teligen.

ASSUMING there's been a fix moving forward, how does this help the folks who already have one of the "pre-fix" cans implanted? Maybe you're a new Boston rep, but I hope you get as tired of explaining the "low" failure rates of the various recalls to worried old grannies as I did.
 






They have solved nothing. SOS different glue.


In my view, many years BSX (Guidant) has manufactured in excess of million cans and have mastered the art of using glue for the header/titanium can joints. I cannot believe there is a need for alternative glue.

May be this glue problem is showing up in only Cognis and Teligen due to the replacement of old defective bleeding headers in stock cans with a newly designed headers.

The rework must have introduced weaker header/titanium can bonding. Looks like someone did not clean the old glue.

Under these circumstances the cans will start showing problems in the field forcing Class I recall.
 












Maybe you should bond an important piece like the header on with more than glue. Maybe the thinness of the can has something to do with the amount of pressure on the glue joint. Maybe when you radically change the dimensions of a can you should change the way you bond the headers. Maybe this won't be your undoing, but I seriously doubt that.
 






Perhaps the can is too thin and it snaps like a cracker. Perhaps they should anchor it and not spot glue it. Perhaps they should mold it to the can rather than glue it. Perhaps BSX regrets the Guidant purchase as much as Tiger regrets getting caught.

I would suggest that BSX regrets the hire of Ray Elliott rather than the purchase of GDT. Evem with all its challenges, CRM CARRIED bsx in 2009. There was good momentum and recovery until Ray came along and started destroying morale, slinging sand from his sandbox over into STJ's to blame THEM for all the bsx problems..All to deflect attention from himself and the real ways he's screwing everything up! Yep, THAT's the biggest regret.
 






ASSUMING there's been a fix moving forward, how does this help the folks who already have one of the "pre-fix" cans implanted? Maybe you're a new Boston rep, but I hope you get as tired of explaining the "low" failure rates of the various recalls to worried old grannies as I did.


It is unfortunate that no lessons have been learnt from the past mistakes; also it is highly unethical to put patients’ lives in to risk.

Rumours are you guys have hidden many things including grossly under reporting failures about Cognis and Teligen cans from FDA, implanting surgeons as well as poor patients. DOJ is already taking action on timely failure to report faults during Guidant days; this is in addition to imposing multimillion dollar fines.

In the past almost all companies have survived by lies, commissions to doctors, hiding design/manufacture/quality problems. This situation will not last long.....
 


















This will eventually only create uglier regulation as boomers move into the picture this decade. More deaths means more media. Power to the people!


This clearly indicates that BSX board and senior management have not learnt any lessons from previous experience (advisories, recalls, FDA warning letters, DOJ imposed large fines etc.). One wonders how long this situation can continue.

I really feel sympathetic towards reps that are continuously being forced to sell defective medical devices to the market endangering the lives of innocent people.
 






The current situation of halting sales and withdrawing all tachy cans was anticipated by all at BSX and its competitors.
Unfortunately BSX has not learnt any lessons from its past mistakes and also from the mistakes by STJ, MTD and few other small companies. It is unfortunate that your culture has not changed at all.
In the end a company having good and effective cans only gain the market share, confidence of doctors, patients and stockholders value as well.
 






The current situation of halting sales and withdrawing all tachy cans was anticipated by all at BSX and its competitors.
Unfortunately BSX has not learnt any lessons from its past mistakes and also from the mistakes by STJ, MTD and few other small companies. It is unfortunate that your culture has not changed at all.
In the end a company having good and effective cans only gain the market share, confidence of doctors, patients and stockholders value as well.

Are you drunk or stoned? Medical marijuana or off the street?
 












I really enjoyed reading this thread. Many good points have been made here and finally as expected these cans have been REcalled!

Someone said let BSX carry their business for a quarter or two without an advisory or REcall, it has been impossible to do so.

There is another thread states "Beginning of the END of BSX CRM"; looks like this is also becoming true!

Nice predictions though.

Have a restful and enjoyable week end.