Complaining to ICD company

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Complaining to ICD company

Post by Theresa » September 20th, 2005, 7:51 am

I recently called the nurse at the ICD company I am dealing with.
I asked her for info on who I would complain to re faulty ICD leads.
I have had 2 leads come out and one had to be capped because it was reading a double T wave. This all added up to 4 surgeries in just over 2 1/2 years.
I'm at the end of my rope. I think the company needs to make better leads. She said she would have the company rep contact my EP and find out what happened,
I don't know what to expect since I think they would need my written permission to discuss me with my doctor. She was assuming NO responsibility for the faulty leads on behalf of her company.
So, I don't know if she was just putting me off. I don't think she is exactly the complaints dept rep as well as being a nurse.
I'm really angry that this happened to me and I don't want it to happen to anyone else.
Does anyone have suggestions for a next move?
Im trying not to alienate the EP's around here since there is no where else to go (small city) and the God complex is alive and well in this part of the world.

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Post by don » September 20th, 2005, 12:30 pm

Hi Theresa

I appreciate your concern. We spoke a little about it on the telephone the other day. I hope Laurie sees this post and replies. She has a greater knowledge of these things than I do.

Leads are normally pretty foolproof. I've had the same leads for about 10 years now with no problem. When leads become dislodged it is often one of two things. One is the patient uses too much arm movement while the leads are new and the tissue hasn't grown around them yet. The other is that the doctor didn't anchor them well.

Double counting T-waves happens from time to time. Common causes are a dislodged lead or a lead placed too close to the diaphram. Double counting can often be corrected by reprogramming the unit.

What I'm saying is that I'm not sure the problem is entirely the leads. The problem could be with the doctor who implanted them.

I'll be interested if anyone on the board has had similar problems and what they found the cause to be. Keep us posted if you hear anything from the manufacturer.




Post by Theresa » September 21st, 2005, 7:09 am

If it is the doctor's fault that the leads came out and/or misread, then I don't feel I can complain. I have a rare disease with one EP in this whole province that can help me and he lives in the same city - it's his team and students that did all the surgeries.
One lead came out 3 months and one week after it was put in and one came out in a week. When the EP put in the ventricular lead, he said 'that's gonna hafta do'!!!! That's the lead that read the double t-waves.
I'm totally disgusted and fed up with the whole ICD thing.

I'm taking it a day at a time with the last patch up job they did - and hoping for the best.

Thanks for your help.

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Post by Shelby » September 21st, 2005, 12:31 pm

Theresa, that sounds so frustrating. I can't comment on the leads themselves, but is there a way you can travel to a different hospital just for lead placement? I'll be praying for you.
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