Cognis..... :(

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It is well known that you guys released these cans with full knowledge of the problems of header and its hardware; even after the Dear Doctor letter you continued to ship these faulty cans to field.

Newly designed header and its hardware were introduced; rumours are possibly you salvaged all the old cans by replacing their header.

Now slowly the pectoral implant issues have crept (good excuse though).

You should now be preparing for a Class I recall.
 












Just wondering about anything being done to Cognis and Teligen cans to make them suitable for pectoral implants?

If so when can we expect new cans (NOT REWOKED PLEASE) in the market?
 






Just wondering about whether FDA has classified Dear Doctor letter of 1 December 2009.


The issues created by:

a) Set screws and header resulting in unnecessary shocks and failure to provide therapies when needed (March 2009 advisory).

b) It is not known about the new set screws, seals and header solved the problems.

c) The suspected reworked cans (replacing the old header with new in stocked cans) created more problems as stated in recent advisory dated 1 December 2009.

Everyone in the industry is expecting this to be a class I recall.
 




































Anonymous said:
Anything done to Cognis and Teligen cans to make them suitable for sub-pectoral implants?

Have you filed PMA suppliment for FDA approval yet?
Click to expand...

Look for the next JACC - apparently there's going to be an article addressing concerns with C/T headers showing signs of failure despite being implanted on top of the pectoral muscle.
 






Anonymous said:
Look for the next JACC - apparently there's going to be an article addressing concerns with C/T headers showing signs of failure despite being implanted on top of the pectoral muscle.
Click to expand...

Conclusion:
Separation of the ICD device header from the titanium case is an unusual cause of
ICD malfunction. This abnormality is NOT limited to the subset of Boston Scientific
Cognis® and Teligen® ICDs implanted subpectorally and may occur in subcutaneous
implants. The malfunction rate for this type of abnormality is not known. Efforts to
determine the rate of header bond abnormality in the subcutaneous population should be
undertaken and should be utilized to guide future patient recommendations.
 






Anonymous said:
Conclusion:
Separation of the ICD device header from the titanium case is an unusual cause of
ICD malfunction. This abnormality is NOT limited to the subset of Boston Scientific
Cognis® and Teligen® ICDs implanted subpectorally and may occur in subcutaneous
implants. The malfunction rate for this type of abnormality is not known. Efforts to
determine the rate of header bond abnormality in the subcutaneous population should be
undertaken and should be utilized to guide future patient recommendations.
Click to expand...

Smells like a recall. Not an advisory, but full blown back to 2005 recall. How long will they wait to "deliver what's next", the "Dear Dr" letter.
 






Anonymous said:
Conclusion:
Separation of the ICD device header from the titanium case is an unusual cause of
ICD malfunction. This abnormality is NOT limited to the subset of Boston Scientific
Cognis® and Teligen® ICDs implanted subpectorally and may occur in subcutaneous
implants. The malfunction rate for this type of abnormality is not known. Efforts to
determine the rate of header bond abnormality in the subcutaneous population should be
undertaken and should be utilized to guide future patient recommendations.
Click to expand...

The separation of header in Cognis and Teligen is naturally a result of poor bond between the titanium case and the header. This must have been the result of removing the defective old header from huge number of stock devices and then replacing with new redesigned header. This operation involve heavy desoldering and epoxy removal and again soldering and joining the header with epoxy. Few delicate hybrid circuits will be involved and these are very delicate parts.

Whether BSX or FDA have checked the serial numbers of affected devices, their batch numbers? I am sure the finger will point towards the devices with may have reworked headers.

Someone should also have thought about achieving reliability of reworked epoxy/solder joints on the dirty cans.

The proper decision should have been steamroll all the stock devices and market newly manufactured and fully validated devices only.

We cannot escape Class I recalls and possibly FDA taking a strong view on BSX inability to design and manufacture reliable medical devices.

BSX should learn something from Toyota about maintaining company's image at any cost!
 






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.
 






Anonymous said:
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.
Click to expand...


Right from the Guidant's VENTAK days to the present Cognis CRT-D (prior to modifying the header and its hardware), the titanium can get detached from the header and resulting in snapped connexions were unknown to Guident. Therefore it must be a new invention by the BSX just like previous RRT (Respiratory Rate Trend) issue to cover up something else. How long FDA will continue to buy these stories?

About the mistake of BSX paying too much to buyout Guidant was a second biggest mistake in the corporate history in the entire M&A world. The first one was AOL/Time Warner.

http://money.cnn.com/magazines/fortune/fortune_archive/2006/10/16/8390284/index.htm
 












Anonymous said:
Smells like a recall. Not an advisory, but full blown back to 2005 recall. How long will they wait to "deliver what's next", the "Dear Dr" letter.
Click to expand...

After last "Dear Doctor" letter, we are in firsat quarter of 2010, the next letter is due now as per the well established tradition of BSX, there will be a letter or two every other quarter.

Also Fot C/T cand a Class I recall is looming as we cannot live longerby lies and more lies!
 






Anonymous said:
Smells like a recall. Not an advisory, but full blown back to 2005 recall. How long will they wait to "deliver what's next", the "Dear Dr" letter.
Click to expand...

It appears that Cognis/Teligen header separations have started in subcutaneous implants.

http://www.theheart.org/article/1047073.do

Secondly BSX on their website claim that 1 December 2009 advisory has been classified by FDA as Class II, however, I could not find anything about this on FDA web site. Could someone confirm about FDA classification please?
 






Anonymous said:
It appears that Cognis/Teligen header separations have started in subcutaneous implants.

http://www.theheart.org/article/1047073.do

Secondly BSX on their website claim that 1 December 2009 advisory has been classified by FDA as Class II, however, I could not find anything about this on FDA web site. Could someone confirm about FDA classification please?
Click to expand...

BSC is screwed. It's ridiculous, these devices have had a black cloud over them for almost 2 years. Wilkoff's comments are interesting, wonder if they have to do with the fact that he has implanted them and doesn't want his patients losing their shit when they hear him saying it's a problem. Self interest at its best.
 






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