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.

6 Comments

Hello

by Penguin - 2023-10-12 11:29:54

Hello Loving Wife, 

Thank you for joining and asking this question. You and your husband must feel very concerned - and maybe a little annoyed that you have to deal with this issue. 

In your shoes I think my first port of call would be the Abbott Cardiovascular Device Rep for your area.  Ask the technicians / EP to call the Rep in to speak to you both and to explain to you why these leads have failed and to determine what Abbott can do to help you? 

I have not been through anything similar and so far mine have lasted 15 years and I frequently read on here about people with older leads than mine.  Mine DO record 'noise' fairly frequently but this hasn't resulted in extraction.  Mine are a different type of lead to yours but are made by Abbott too. 

I would research the reliability of the newer MRI safe leads before you do anything or commit to any payments. 

This may be a good place to start: 

https://www.medscape.com/viewarticle/906660?form=fpf

You will not be able to click on the link as this forum doesn't allow this. You will need to copy and paste it into your browser.  A quick glance at the article suggests that your husband is not alone. 

Best Wishes

 

leads failing is not uncommon

by Tracey_E - 2023-10-12 11:36:07

Leads last on average 15 years. Some last a lot longer, some like your husband's don't last nearly that long. 

It sounds like there is a rupture in the insulation. I had this happen. They have to turn up the juice to get it to pace. Picture a leaky hose. They can turn up the signal and it will still work normally but it will shorten battery life. Unless it's causing problems, they usually wait out the battery and replace everything at once. If it said 4 years left but they just turned it up, it could be a lot less than that. I would ask about waiting until the battery is used up. 

They used to simply add a new lead if one went bad and there was room in the vein but that means leaving in old hardware. That was in the days when extraction wasn't an option or it was new and risky. Now extraction has become fairly routine and most docs prefer to get the bad hardware out and start fresh. His is not old enough to make this complicated. 

Extraction is done by catheter. They use a sheath with a laser that separates the lead from the scar tissue. The main thing to know about it is you want someone who specializes in it doing it, not someone who just does it occasionally. 

It's unfortunate, but this is not an uncommon thing to happen. No one is at fault and there's nothing to report to the FDA, and I highly doubt you'd get anywhere trying to get St Jude/Abbott to pick up any of the cost since it's more than 5 years old. My two concerns would be does it need to be done now or can it wait until the battery goes, and who will do it. You also might ask if he qualifies for leadless. They have come a long way in the last 5 years. It's possible they could remove the leads and go leadless. 

 

Lead failure

by Aberdeen - 2023-10-12 15:59:49

I have a CRT pacemaker (implanted May 2020) In November 2021 I started feeling unwell on occasion so I was sent for an echocardiogram. Nothing had changed since my previous echocardiogram. I have a moderate mitral valve leak. These  occasional  dizzy spells and feelings of being below par and on one occasion lights flashing continued until April 2022. 
In April 2022 the pacemaker clinic got in touch with me and asked me to see them as soon as possible. I have a bedside monitor but it didn't pick up the lead failure until April.

I was told my RA and RV leads had failed and had to be replaced. This was done the following week. I was told that the method of placing leads by subclavian access can lead to lead failure in very rare cases.

The surgeon replaced the leads easily as they hadn't been in place for a long time.

Since then I have felt very well 🤞🤞🤞.

I hope that you too have a good outcome!

Medical adhesive

by JaneJ - 2023-10-14 03:28:41

My atrial lead which is almost 20 years old had some fraying of the outer insulation when I had my last battery change, about 6 yearsago, and  the rep for Boston scientific had a medical adhesive the dr used to repair it.  Not sure how often or what circumstances they use it for....Hope they are able to resolve your husbands problem soon!  Take care!

Leads

by Lavender - 2023-10-14 07:47:32

Why won't your insurance cover this? Most will if it's medically necessary. I have a lead only under three years old that's using up a lot of voltage and running down the battery. I'm not happy about that but as soon as the battery gets low enough, insurance will pay. 
 

Jane-that adhesive sounds amazing. Can't believe they can go in there like that for a repair!

THANKS!

by Loving Wife - 2023-10-15 10:27:12

This is all excellent information. I'm very grateful for your knowlege and support. Thanks a million. We will do some more reading, but now I feel like I at least have a good idea of where to start and what questions we need to ask before taking the next step.

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