Recall

Thank you Finn

by Gemita - 2021-12-09 09:49:31

If you wish, you could take a photo of the Notice and then place it in the Gallery, where we can all view it?  In the meantime, try not to worry.  You would soon know from any symptoms you might get if your device is malfunctioning.  Hopefully you will get many years of good service from your Abbott/St. Jude.

I think this is probably the link (copied from a post below):

https://www.fda.gov/medical-devices/medical-device-recalls/abbott-formally-known-st-jude-medical-recalls-assuritytm-and-enduritytm-pacemakers-potential

same

by Tracey_E - 2021-12-09 10:07:43

There are two other posts about this if you scroll down. I didn't get a letter but when I saw the notice and realized I had the model and dates in the recall, I reached out to Abbott who confirmed I'm part of the recall. This was just yesterday, have not heard back from my doctor yet but it appears the bottom line is don't delay scheduling replacement when it reaches ERI because it can deplete faster than expected. It's not going to suddenly stop so as long as we continue with regular Merlin downloads, it's nothing to worry about. Premature battery depletetion is very rare, something like 115 out of the thousands of devices affected. If we are one of the very few where that happens, Merlin will alert the doctor's office. 

more info

by Tracey_E - 2021-12-09 17:31:49

I heard from my ep, longer explanation in the other post. Only action to take is continue quarterly monitoring. 

Premature battery depletion

by crustyg - 2021-12-10 04:20:48

Pardon me for disagreeing, but some vendors have had significant issues with this (Boston Sci springs to mind).  There's an active Class 2 recall notice for a range of Boston Sci PMs - well over 100,000 of them:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187851 70k Accolade units

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=187839 31k Essentio units

..and there are more.  This is yet another premature battery depletion notice for Boston Sci.

*BUT*, on the whole, implantable cardiac device batteries do well.  There are a *lot* out there, giving good service (for me, so far, so good!).

crusty

by Tracey_E - 2021-12-10 12:52:19

What are you disagreeing with? That the current Abbott/St Judes recall is nothing to worry about? Wondering if you possibly misunderstood the original question. 

https://www.fda.gov/medical-devices/medical-device-recalls/abbott-formally-known-st-jude-medical-recalls-assuritytm-and-enduritytm-pacemakers-potential

I'm part of this recall. After talking to Abbott and my ep, and reading the FDA notice in full, I'm not even the tiniest bit concerned. The percentage of units affected is very small (135 total of thousands in use) and Merlin would show reduced battery life. My ep elected not to mention it to patients who regularly report in with Merlin and show no irregularities on the reports.  I agree with this and was not the least put out that I read about it here rather than hearing it from my doctor. Am I missing something? 

No, and I thought about the wisdom of posting about the scale of the Boston Sci recall

by crustyg - 2021-12-10 17:33:59

Hi Tracey: Your comment 'premature battery depletion is very rare' was what I was disagreeing with.  As a proportion of implanted devices it seems like a small percentage - and I fully accept that it seems likely that only some of the 100k devices for the Boston Sci recall will actually exhibit premature depletion.  It just isn't that rare.

However, I would agree that premature battery depletion due to failing leads (poor heart/lead junction, cracked leads or insulation damage at implantation time leading to electrical leakage) is probably a commoner cause of battery depletion leading to device replacement, judging by some of the posts I've seen here.

Perhaps I'm just being grumpy... (as if!).

ah

by Tracey_E - 2021-12-10 18:08:17

I was saying the odds of rapid depletion are very low for devices affected by this  particular St Judes recall. 

In my 5 devices, I've had rapid depletion once. My 3rd one lasted 2 years due to a bad lead, ruptured insulation so they cranked it way up to keep getting the signal through. 

We've never had anyone be grumpy here before ;o)

Who's,Grumpy......🤬

by Marybird - 2021-12-11 10:46:58

Nahhhh, never..... 

I just wanted to say how much I appreciate the back and forth about this particular "recall",  and I hope the information, especially what you've provided, Tracey, will go a long way towards easing the anxieties of the OP ( KristinL) or anyone else,who might be concerned, about the issue. It seems a very few pacemakers have been, or will be affected by the recall, and with the normal monitoring carried out with pacemakers, should a problem occur, it would be picked up soon and addressed ASAP.  Seems to me the letter to physicians from Abbott emphasizes the importance of encouraging pacemaker patients who tend to be lax about their monitoring instructions, especially if they're pacer dependent, to get with the program. 

Otherwise, I'd have to agree with Tracey's EP, about not contacting patients who already are compliant with their monitoring, follow up visits, just to avoid unnecessary anxieties about the issue.

Still don't think my pacemaker is affected- looking at the serial numbers of the Assurity pacers listed on the FDA website, the serial number on mine is significantly higher ( 7 digit number, mine is 90....., the serial numbers listed on the affected list are all 7......).  The comment made by Finn, I think it was, about his pacer being affected by the recall after they moved their list ahead gave me pause for thought ( could that happen to me)? But really, no reason for concern.

Thanks everybody for the input. 

Dates

by Finn - 2021-12-14 10:29:24

Hi, I did check the serial numbers , in the fda report, I missed by two months but I called directly to Abbott and they have added more units which included mine starting, 90....

also I asked about the "letters" going out, Abbott said your Dr/ clinic should notify you not Abbott.