data on new implant
just had new ICD implanted 1/28/10...Boston Scientific CRT-D Model N119 171701. Trying to get as much data as I can about company and device. Had a St. Jude pacemaker before this one. Appreciate any info of websites. Thanks
5 Comments
ICD - Boston Scientific
by Blessed one - 2010-03-10 05:03:45
II had my Boston Scientific CRT-D implanted 6-17-08 -Model H220 - Serial 510483. It is and has been pacing
and shocking just fine. The last time the Defib went off
my doctor changed the settings and put me on a new
medication called Sotalol to arrest the arrthymia and so
far it seems to be working.
The ICD - my communicator, scale and BP are all working and sends information to my doctor every
Monday. This is just great because I don't have to
report to his office unless there is problem. I am
truly blessed with each of my doctor's , they are all
excellent and keep in touch with one another anytime
I have an appointment.
Since being wired I have had to make adjustments and
at first it was very difficult because I have to think about
what I am going to do and will it affect my unit and or me. But, I thank God for this blessing as it means I
are alive, well and bionic!
So all I can say is this particular unit by Boston Scientific - Guidant is excellent. Hope this helps.
Have a wonderfully blessed day.
Blessed One
BS CRT-D model
by cbaker - 2010-03-10 11:03:12
Well, not to sound alarmist, but there was a recall last month that affected this device specifically. Obviously I would guess that improvements have (already) been made, but I'd guess you might just want to check with your EP or Boston Scientific, at least just in case:
----------------------------------------
Date Posted January 13, 2010
Product: Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119.
Recalling Firm/Manufacturer
Boston Scientific CRM Corp4100 Hamline Ave NSaint Paul, Minnesota 55112-5700
Reason for Recall: Engineering simulations and field reports indicate that in some cases, implanted devices may encounter sufficient mechanical stress to weaken the bond between the header and case when positioned subpectorally. A weakened header bond may alter lead impedance and introduce noise
Action: Boston Scientific CRM issued an "Urgent Medical Device Correction" letter dated December 01, 2009. The letter described the issue and potential device behavior. The letter provided recommendations to avoid issues relating to the affected device until improved devices become available.
For further information, contact your local Boston Scientific CRM representative, United States Technical Services at 1-800-227-3422.
BSX Cognis and Teligen Class II Recall
by mrroerockhead - 2010-03-13 04:03:38
Here is your information.
Device Lookup Tool Results on 3/13/2010 03:04 EST
Model Number: N119
Serial Number: 171701
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, 80.3 KB)
The device lookup tool provides information concerning product advisories issued to physicians since January 2005. For earlier communications, please see our product performance report.
.
The FDA classified this advisory as a Class II recall on January 13 2010.
At this time the recall pertains to subpectoral (under the muscle) implants only.
Please check the Boston Scientific website for further information and talk with your EP doctor.
http://www.bostonscientific.com/home.bsci
Hope this helps.
Nothing better than an educated patient!
BS recall etc
by cbaker - 2010-03-14 09:03:24
mrroerockhead, are you a device rep? (No problem if you are; just wondering.) Your information is not quite up to date. The current controversy about the device in question is whether it involves subcutaneous BS devices as well.
Fisherman, here are two articles that describe the discussion:
http://cardiobrief.org/2010/02/08/new-concerns-raised-about-boston-scientific-icds/
http://cardiobrief.org/2010/02/10/boston-scientific-and-william-maisel-clash-over-icd-flaws/
Fisherman, I don't mean to imply you should worry! But you might want to communicate to your EP that you know this device has been in the news (after all, since the EP chose that device, obviously he or she is going to say it's a good device) and just ask if there is going to be close monitoring of any potential problem. That's what I'd want to know, and it might encourage the doc to keep a closer eye on you.
Good luck & happy March.
You know you're wired when...
Your favorite poem is Ode to a Cardiac Node.
Member Quotes
I am 100% pacemaker dependant and have been all my life. I try not to think about how a little metal box keeps me alive - it would drive me crazy. So I lead a very active life.
Boston Sci
by mjmellon - 2010-03-10 01:03:50
Had my Boston Scientific CRT-D implanted on Feb. 18th Model N119 serial 958603. I was able to down load 500 page manual off of their web site. had more info than I needed. one thing that seems kind of odd to me is the huge differance in serial #'s between yours and mine. Wonder what MFG date is? and was unit manufactured post recall.