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new icd has glitch
Barely out of the starting block with their new model of implantable cardiac defibrillators, Boston Scientific issued an advisory (pdf) on their new line of COGNIS CRT-D and TELIGEN implantable cardiac defibrillators. TELIGEN ICD products, model numbers E102, E110, F102, F110 and COGNIS CRT-D products, model number N106, N107, N118, N119, P106, P107 are affected.
This line of ICD's has a sensor that detects the patient's respirations which can be programmed ON or OFF. This advisory only affects the devices with this respiratory sensor programmed ON. It seems at this setting, certain potential right ventricular lead complications such as chronic lead fracture and acute lead connection issues may cause additional oversensing, thereby increasing the probability of the device failing to pace appropriately or giving inappropriate shocks. The company recommends programming the sensor to OFF, thereby correcting the problem.
4 Comments
Old News vs New News
by mrroerockhead - 2010-02-28 04:02:34
Hello.Mikej,
I see your post is dated February 26 2010. Actually this article is old news from BSX. You may want to read the new FDA class II recall on their Teligen/Cognis subpectoral implant( possible sub-q implants too). Dear Doctor letters went out in December and the FDA class II recall came out in January. From what I am hearing these cans will probably be class I recall by the second BSX quarter. I will try to attach the BSX website information for these cans, otherwise you can check BSX CRM reports from their website. Makes me sad, I already went through the ordeal of the recalled Medtronic cans and leads! Still have not recovered from that one and now this one is having over my head. I do have a Teligen can in a subpecotoral postion. I would be interesting in reading how many poeple have this prodcut implanted in a subpectoral postion and their doctors have to say about it. It could be interesting eh? Life if grand eh? Best of luck. Here is the webisite for BSX http://www.bostonscientific.com/templatedata/imports/HTML/PPR/ppr/support/current_advisories.pdf orhttp://www.bostonscientific.com/templatedata/imports/HTML/PPR/ppr/support/current_advisories.pdf Please let me know how you are feeling about this recall and what your plans are to deal with it. Thank you very much.
MrJoeRockehad.
Please help
by Laney - 2010-03-10 11:03:28
Hey Mr Joe :-)
I am so new at all of this (11-30-09) that I feel like I still have the price tags on my ICD...
Below is the information I have about my device; would you please tell me if the ICD I have is on the recall list?
Mfg Product Model/Serial
Boston Sci CRT-D N119 180243
Guidant Lead 4555 180650
Guidant Lead 4136 28499899
Guidant Lead 0185 307167
Thank you and God Bless
Elaine Skinner eskinhealinghands@yahoo.com
BSX Cognis and Teligen Class II Recall
by mrroerockhead - 2010-03-13 04:03:34
Hello Elaine,
I think I was half asleep when I typed that last post.
Must have been post Ambien load at 0431!
Here is your information. Remember, this recall is for subpectoral implants only and if you have any concerns/questions please call your EP physician. K?
Device Lookup Tool Results on 3/13/2010 03:40 EST
Model Number: N119
Serial Number: 180243
The device identified by the COGNIS 100-D model and serial you entered is part of:
1.The Subpectoral Implant 2009 product advisory was initially communicated on 12/1/2009 .
¡This advisory only applies if the device is implanted in a subpectoral location (between the chest muscle and ribs). Devices implanted subcutaneously (just under the skin but above the chest muscle) are not included in this advisory.
¡Patient Letter communicated on 12/1/2009 (PDF format, 27.6 KB)
¡Physician Letter communicated on 12/1/2009 (PDF format, 80.
You know you're wired when...
The meaning of personal computer is taken a step further.
Member Quotes
Sometimes a device must be tuned a few times before it is right. My cardiologist said it is like fine tuning a car.
Mike!!
by Pookie - 2010-02-26 04:02:27
I've been wondering where you have been lately.
Is everything okay with you even though you have this particular defib?
Pookie