Is Lead Failure after 5.75 Years Unusual?
First-time poster here, and thanks in advance for your guidance.
My 65-year-old healthy and active husband, who is 100% paced, has had incidents of "noise" over the past year. Five months ago the docs fiddled with his settings to try to eliminate it, but he still gets it now and then -- so he was called back in to the office again. This time, they had him move his arms around, and when he stretched his left arm across his body, they could see something on the monitor that they didn't like. Apparently, it's a sign that the lead's insulation is shifting (I think?) exposing something that shouldn't be exposed.
I don't understand it all, but we were told it's a sign that the lead is failing and it needs to be replaced. It's a Tendril lead, which I've read has a higher incidence of early failure than other leads.
I'm pretty disappointed and upset, as I hate to see him go through another surgery, and it will cost us thousands of dollars, too. They recommend extracting the old leads -- which sounds scary to me -- and replacing the pacemaker (which has 4 years of battery life left) with a new one.
Has anyone else gone through something like this?
Should such an early failure be reported to the FDA?
I feel like the manufacturer should bear some of the costs of the procedure, as their product seems to be defective. Am I out of line for feeling that way? Or should I just let that go and totally focus on my husband's well-being?
And finally, should I just go along with whatever type of pacemaker and leads the surgeon wants to use? I asked, and they still use Tendril leads, but not the same model. I'm very nervous about that, because I don't want him to have to go through this again in 5 more years.
Here are his pacemaker stats:
St. Jude pacemaker: Model Number PM2272 and Serial Number 7962005
Implant Date: Dec. 21, 2017
RVA-Lead LPA1200M/58 CBB150413 and RA-Lead LPA1200M/52 and DBN029107
Thanks so much. After reading some of your posts, I realize how little I know about all these important issues.
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