IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

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hugooc
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IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by hugooc » December 10th, 2009, 1:05 am

Boston Scientific has issued an advisory on COGNIS and TELIGEN devices worldwide implanted below the chest muscles. Only COGNIS CRT-Ds and TELIGEN ICDs implanted below the chest muscles (subpectoral implants) are affected by this advisory.

The problem seems to be that the bond between the translucent header (which holds the leads) and the metal case (which contains the pulse generator) can be weakened by a patient's pectoral muscles pushing against the ribcage.

No deaths have been reported. And, to date, there have only been two reports worldwide of implants with weakened header bonds. The patients implanted with these devices received inappropriate shocks and required early device replacement.

Boston Scientific has already notified doctors and the FDA. In fact, they have already submitted manufacturing process improvements to the FDA, and will implement those changes when regulatory approval is received.

According to Boston Scientific, a weakened header bond can result in one (or more) of the following:
  • Significant changes in measured lead impedance
  • Noise on real-time or stored electrograms
  • Intermittent inhibition of pacing
  • Inappropriate anti-tachycardia pacing or shock therapy
  • Loss of pacing therapy
  • Loss of anti-tachycardia pacing and shock therapy
What you should do:
  • If you don't already know what type of device you have, check your ID card to determine whether you have a COGNIS or a TELIGEN. If you don’t have either, this advisory does not apply to you.
  • Talk to your doctor to determine whether your device is implanted under the skin (subcutaneous implant), or under the chest muscle (subpectoral implant). The odds are in your favor. Most devices (95%) are placed under the skin. Only about 5% are placed under the pectoral muscle. If your device is implanted just under the skin, this advisory does not apply to you.
  • Attend your regular device follow-up appointments
  • Immediately contact your device doctor or clinic if you receive a shock
Boston Scientific has contacted us this morning and explained that they recognize the importance of advocacy groups "as important and credible resources for patients."

More details, including contact information and phone numbers on the blog, here:
http://bit.ly/COGNIS

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Mark
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Re: IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by Mark » December 10th, 2009, 7:35 am

Thank you Hugo!

This is the important information that needs to be known to all ICD Boston Scientific recipients that fall into this category. As a group, patient advocacy is most important and knowledge is definitely power when it comes to our heart heart health.

Of course, as it has been mentioned here before, device manufacturer accountability is what increases our trust in our manufacturers workings. Please read the post and follow the link, and continue on with phone calls to your doctor and company with any or all questions.

Remember, information is what keeps us all healthy and safe. Again, a huge thanks to Hugo for this!
~Mark Mark passed away on November 3, 2013
"The mind is like a parachute, it only only works when it is open"- Frank Zappa
Round One: ICD implanted Feb. 2006: Medtronic Intrinsic, 2 leads- St.Jude 1388tc (Atrial), 6947 Medtronic Sprint Quattro Secure (RV/SVC).....
Round Two: July 17 2011, meet Medtronic Virtuoso 2 DR- same leads, cleaner scar.
5 shocks whoooo hoooo! Image Run Matilda, Run!

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ram1025
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Re: IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by ram1025 » December 14th, 2009, 10:31 pm

I am friends with two Boston Scientific Reps - one in Chicago and one in New York City. I had lengthy conversations with both of them after hearing about this. I have the Teligen 100. The patient letter did not advise us (nor did my doctor) that both of these incidents happened in larger people (it has to do with the pressure that the muscle puts on the head of the device - causing "noise) - and both of these incidents were on COGNIS DEVICES. Boston Scientific has always grouped Cognis and Teligen together whenever reporting to the FDA or anyone because they are so similar but these incidents were on the Cognis. If you look at both devices (I have plastic samples both sitting here on my desk) - you can tell the difference - the Cognis has a taller head, thus they said there is more pressure on the head. They said that they are now using better adhesive to attach (or seal - i can't remember what word they used) the head. If you want me to post pictures of both devices, I can.

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~guin
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Re: IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by ~guin » December 15th, 2009, 12:06 pm

You can see photos at this site:
http://icdusergroup.org
~guinImage :hrt :hrt :hrt :hrt :hrt
http://icdusergroup.org
Familial Dilated Cardiomyopathy
Sub Pectoral ICD Implant 9/1999
Medtronic Dual Chamber Evera XT DR
Replaced: 3/2000, 3/2006 & 9/2013

'Folks can be as happy as they make up their minds to be.' - Abraham Lincoln

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Ozchrissy
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Re: IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by Ozchrissy » December 17th, 2009, 4:56 pm

Thanks Hugo, I will be having a Boston Scientific when I need my device replaced, so will have lots of questions. I am not sub pectoral, and he won't do it that way due to the problems associated with moving from chest to subpectoral. But still, need to know the problems associated and the risks. The last thing I want is inappropriate shocks, have had 4 excellent years with this device, don't want any complications with my new one.
“I am not what happened to me, I am what I choose to become.” Carl Jung

Diagnosed with cardiomyopathy in 10/99
LBBB & VT diagnosed Feb 06
Guidant Biventricular Pacer ICD inserted Feb 06: Boston Scientific Incepta CRT-D inserted May, 2012
Oesophageal Cancer, 2012, Gall Bladder & Septicemia 2014 resulting in VFib and severe heart damage
Bare Metal Stent May, 2012 Mitral Valve replaced 2015
Meds: Entresto, Bicard, Coralan, Eurtorxsiq, Frusehexl, Spiractin, Sigmaxin, Creon, Warfarin,
Appropriate Shocks for Ventricular VFib.

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wen
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Re: IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by wen » December 17th, 2009, 6:22 pm

Thanks Hugo,

I do have the Teligen but it's implanted just under the skin. I appreciate you keeping everyone so informed!
You're awesome!

Wendy
Left Bundle Branch Block
Non-ischemic Cardiomyopathy
V-Tach
ICD-Boston Scientific Teligen (2-lead) installed 7-7-09

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LMT033167
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Re: IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by LMT033167 » December 23rd, 2009, 7:45 am

Sorry, this may sound like a dumb question, but how do you tell if your icd is implanted just under the skin or sub pectoral?

I can't remember and I don't go back to the EP until the middle of Jan. I'm looking through my surgery paperwork, but have no clue what I'm looking at :P

edit: it does say "A prepectoral pocket was dissected" that's the only thing it shows
Lisa
8/26/2009 Cardiac Ablation, Malignant polymorphic VT, Bradycardia, 50,000 pvc's
(SCA during surgery after sustained VT & V-fib 3 times)
8/28/2009 Telgien PM/ICD implanted
Non-Ischemic Cardiomyopathy Trace MVP; Mild Tricuspid Regurgitation; LVH

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hugooc
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Re: IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by hugooc » December 23rd, 2009, 11:09 am

LMT033167 wrote:...it does say "A prepectoral pocket was dissected" that's the only thing it shows
You found it! "Prepectoral" means the generator was placed under the skin. Your device is not affected by the advisory.

oleblueize
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Re: IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by oleblueize » January 10th, 2010, 8:18 pm

This is my device- I guess I better read my surgical notes too. Thanks for the info.
ICD CRT-D 2/2/09

michelle
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Re: IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by michelle » April 16th, 2010, 3:26 pm

I guess I should check with my doctor...I have the Teligen and it is under the muscle.
Michelle
___________________
Implant 10/30/2008
TELIGEN IS-1/DF-1 DR

garya
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Re: IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by garya » April 28th, 2013, 1:52 pm

The last post on this 'important' announcement was over 3 years ago. Can we safely assume that if a person effected by this product advisory has not heard already from Boston Scientific or their cardiologist or there EP, that they probably have died? And if so, is the "important" announcement still necessary at the top of the forum? If anything, it makes things look dated and when there might be a newer "important" announcement, it increases the chances that no body is reading these anyway. 9/11 was an important announcement, the housing market crash and Obama getting elected and even re elected are "important" but also basically old news. Just my thought on deleting or moving this thread.

While we're here
"Prepectoral" means the generator was placed under the skin. Your device is not affected by the advisory.
What if I don't have my surgical notes, is there a way to tell? I would suspect if you can see the outline of your icd or relatively easily feel the device, you have "prepectoral" meaning just under a layer of skin. If you also did NOT have quite a bit of discomfort over a few weeks after implant, then my guess is they did NOT cut into the prepectoral muscle which would result in increased pain and suffering.

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Ozchrissy
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Re: IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by Ozchrissy » November 19th, 2013, 5:02 am

Oh Garya, you remind me so much of someone from our past, are you by any chance related to Don???
“I am not what happened to me, I am what I choose to become.” Carl Jung

Diagnosed with cardiomyopathy in 10/99
LBBB & VT diagnosed Feb 06
Guidant Biventricular Pacer ICD inserted Feb 06: Boston Scientific Incepta CRT-D inserted May, 2012
Oesophageal Cancer, 2012, Gall Bladder & Septicemia 2014 resulting in VFib and severe heart damage
Bare Metal Stent May, 2012 Mitral Valve replaced 2015
Meds: Entresto, Bicard, Coralan, Eurtorxsiq, Frusehexl, Spiractin, Sigmaxin, Creon, Warfarin,
Appropriate Shocks for Ventricular VFib.

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beachjay
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Re: IMPORTANT: Product advisory issued on the COGNIS and TELIGEN

Post by beachjay » November 19th, 2013, 9:32 am

lmao4dx
Jacky in Texas

Time you enjoy wasting is not wasted time.....Bertrand Russell

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