Sprint Fidelis

I attended a Medtronics seminar at the local hospital yesterday evening. The meeting was a result of the re-call notice on four models of the Sprint Fidelis leads.

The company and the docs all admit that there could be a problem with the leads cracking, but there doesnt seem to be anything really conclusive at this time. The recall is reported completely voluntary.

For those in attendance who were interested, they re-set the sensitivity of our ICD so that the audible will sound if there is a problem - or potential problem.
The general recommendation seems to be close monitoring. There are no general plans to replace the leads leads at this time, as this could create more problems.
If anything, they would cap the cracked leads and put in new leads.


10 Comments

thanks for the info

by mandogrl - 2007-11-09 09:11:12

I called my Dad-in-law to make sure he knew about this. They had just set his audible alarm yesterday, but they assured him there's almost no chance of a problem.

Dad's lead fractured June 07

by travelingreids - 2007-11-12 10:11:25

My dad's lead did fracture in June 07. At the time we did not know about this problem with these leads. To my surprise, when we did hear about it (Oct 07), I had my dad check his ICD card and lo and behold, they replaced the fractured lead with the same model.....We have a visit with the Medtronics rep tomorrow to find out what is next, but my Dad is so depressed now I dont know what to do. When they replaced the fractured lead back in June, the dr then said his viens were so small that this is the last one he could get in. So my question now is what if this one fractures, wonder what we do.........You all talk about turning on the audiable beep - how is this done? Can the rep do this or is surgery required?

Thanks

ding a ling

by PreciousDays - 2007-11-12 10:11:59

My audible alarm was set one week ago. I am afraid I have lost all respect for the medtronics rep. working with me. Somehow he seemed to think that by setting me sound like my cell phone he had solved any potential problem. - I was already having a hard enough time dealing with heart failure, cardiomyopathy, and the whole concept of a pacer and defibrillator at the relatively young age of 46. - now - (in all seriousness) every time I hear a faint chime - it makes me cringe. Gotta love the idea of for profit health care. It might not make us well - but it makes a profit for those at the top. - Sorry - I guess my anxiety is making me snarky. Just out of curiosity - how are other people handling this little error? P.D.

The alarm

by PreciousDays - 2007-11-13 09:11:49

The audible alarm is set externally - the same way the pacer is adjusted when they mess around with the settings. I am so sorry to hear about your dad. Antidepressants can be helpful for cardiac patients - encourage him to talk to his doctor about it - or mention it yourself to the doctor if your dad isn't comfortable with talking about it.

Best,
PD

Medtronic's Pacemaker check

by travelingreids - 2007-11-14 08:11:19

My dad had him pacemaker check yesterday with Medtronics rep. Previously his defibulator was programmed to do a "check" of the battery voltage and lead integrity at 1 am every day. But we were not aware of this. The rep increased the sensitivity level from 2500 to 1000(whatever this means). It will do the check still at 1am every night and if problems detected, the alert is scheduled to go off at 9:10am the next morning. She said this would detect battery voltage and the integrity of the lead(s). If he hears the 'faint' alert, he is to go to dr to have it checked out. She also said his pacemaker/defibulator was set to 18 beats to see if his heart was out of rythm (a-fib). She stretched that window out a little more to allow the defibulator time to distinguish if it is noise or actual a-fib that it is reading.

I am not sure if this mad my dad more at ease or just that he will be waiting on "9:10am" every day. She also ask if he had been given a "donut magnet". He has and she instructed him on how he can check the defibulator with it. Has anyone else done this?? Is this really safe?

Dad cant have his leads removed, and has no room for new ones in the existing veins. Not sure what we will have to do if every need to do this. Hopefully he will have better luck the second time around with his leads....

Janice

Alarm

by vaigneurg - 2007-11-16 04:11:02

I had my defib installed a year ago and have been very happy with it. However, I also have the lead 6949. I saw the Medtronic rep on Tuesday and he set my alarms to sound everything 24 hours at 7 p.m. Wednesday night the alarm sounded (much to my dismay) and I had to see the rep again on Thursday. He noticed a spike above 1000, but could not determine why. He reset the alarms again and they are scheduled for 7 pm again tonight. Because tomorrow is a Saturday I will have to go to the ER according to him. You are right, this is quite nerve wracking. Wish me luck for a quiet 7 pm alarm.

Gail

Medtronics pacemaker check

by shovelhead - 2007-11-24 06:11:45

Janice,
I have very narrow veins, and one of the "suspect" leads. My EP doc, said we could move everything to the other side and use a different vein. This might be an option for your dad.
The phone check in is easy to use, painless, takes about half an hour. I think of it as my device is sending a FAX to the clinic.
Good luck!
Debbie

leads

by jhall - 2007-11-25 01:11:32

Hi, I'm new to this , but wondered if anyone like me . this past feb , had my 4th device implanted this one the combo pacer and defib. I too received a new lead with the recall numbers. Have lived by these devices since 91' and am thankfull to make it to 57 yrs .. i would be courious to hear medtronics answer to what a person who is 100% paced is to do if that lead fails
thanks--------jhall

Medtronics lead did fracture (6949)

by travelingreids - 2007-11-29 11:11:02

My dad's lead did fracture in June 07. At the time we did not know about this problem with these leads. To my surprise, when we did hear about it (Oct 07), I had my dad check his ICD card and lo and behold, they replaced the fractured lead with the same model.....We had a pacemaker check on 11/13 with a Medtronics rep. Previously his defibulator was programmed to do a "check" of the battery voltage and lead integrity at 1 am every day. But we were not aware of this. The rep increased the sensitivity level from 2500 to 1000(whatever this means). It will do the check still at 1am every night and if problems detected, the alert is scheduled to go off at 9:10am the next morning. Rep said this would detect battery voltage and the integrity of the lead(s). If he hears the 'faint' alert, he is to go to dr to have it checked out. Rep also said his pacemaker/defibulator was set to 18 beats to see if his heart was out of rythm (a-fib). She stretched that window out a little more to allow the defibulator time to distinguish if it is noise or actual a-fib that it is reading. I am not sure if this mad my dad is more at ease or just that he will be waiting on "9:10am" every day to see if he hears the alarm. Rep ask if he had been given a "donut magnet". He has and she instructed him on how he can check the defibulator with it. Has anyone else done this?? Is this really safe?

Even with all this, my Dad is so depressed now I dont know what to do. When they replaced the fractured lead back in June, the dr then said his viens were so small that this is the last one he could get in. Hopefully he will have better luck the second time around with his leads....

Janice

Lead Recall/hard for me too.

by bunnykin - 2008-01-05 06:01:08

Having read and shared with all of you about this lead recall thing is a bit of a consolation for me. Reassuring? Not really cos it's definitely a problem, and in the future say 6 months one year down the road, who can say? My own experience is horrendous too. I've got lead extraction twice since 2004 and 2006. First one was due to VT detected and had to change from PM to ICD and new defibrillator lead implanted. Second time was that ICD lead was perforating my heart over time! It actually migrated over time and that was a scary experience so 2006 I had another lead replacement; Unfortunately that new one reimplanted was the one now under recall, Sprint Fidelis. I couldnt agree better with Mr. PD(precious days) that we tend to get absolutely annoyed when we draw up an account about our lead problem. Worse of all I'm also pacemaker dependent and cannot take any chances if this lead starts to fracture...got to start running to my Dr when I hear myself "chime". It's not much of a life to live in fear. For a small frame like myself my dr will defintely remove the lead if problem starts, no way he can cap it and put in another one! Chances of blockage of blood flow is high for smaller physique patients. My cardiologist friend advises closely monitoring of ourselves despite whatever Medtr. people say, cos they agree that 4000-5000 (2.3%) people will experience a fracture in a 30 month period.May even be more in long run who can say. Just need to be more vigilant and listen to our alarm carefully. Hopefully, the alarm works too!!! I'm getting paranoid...I've been using Medtr. all these years since 2002 and had lots of mishaps. Yet, and i say yet, thank God I'm still here today. You all take good care and have a healthy new year. All the very best for 2008.




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Your pacemaker interferes with your electronic scale.

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