Pacemaker recall - Abbott

Recall

by AgentX86 - 2021-12-07 14:07:48

I don't have a St. Judes (Medtronic) but unless you are truely pacemaker dependent (heart won't function, at any level, without it) I wouldn't worry too much.  The incidence of the failure 5 units per 10,000 so it's not like every one is going to fail. Again, if it fails and you're not dependent, you'll likely feel something (bad, I would presume) but not life threatening.

Pacemaker "Recall"

by Marybird - 2021-12-07 16:48:25

This is the link I posted regarding this recall to the PM I sent to Kristin in response to her PM to me on the topic. It's from the FDA website. It explains pretty much what is involved in the recall- not really a recall but more of a heads up.

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

do you have a Merlin home monitor?

by Tracey_E - 2021-12-07 21:16:05

Merlin will be checking in regularly and will alert your doctor if there is a problem. It's not a time bomb. If they felt it could suddenly stop, they would be sending you a letter about having it replaced. This is not that. 

What I got from the FDA notice is at the end of service, don't mess around getting it replaced because it can switch from ERI to EOS faster than expected. Expected is 3 months but it doesn't suddenly stop after that. It switches to another mode (EOS) which also lasts 3 months where it paces at a steady 60bpm which is safe but if we are dependent doesn't feel too good. You may not have the full 6 months once it switches modes but most of us don't mess around once it switches modes anyway. They tell me it switched, I pick a date and have it replaced usually within a couple of weeks. I'm on #5 so I'm probably more blase than average about replacements. 

As long as you go for your regular checks and your Merlin is working, there is nothing to worry about. This sounds a lot worse than it is. 

me too

by Tracey_E - 2021-12-08 16:15:07

So, my device is on the list too. When I looked up the details before responding to your post I noticed it was my model and the years covered are when I had my last replacement. I never got a letter from my doctor so reached out to Abbott, who responded that my device is indeed on the list. So, recall twinsies! I'm going to ask my doctor about it. I still don't think this is anything to worry about but I will touch base with them. If I learn anything new, I will let you know. 

Letters

by Marybird - 2021-12-08 21:00:38

Tracey, from what I can see the letter to the patient whose pacemaker is involved in that recall/watchlist comes from Abbott, and it looks as though they have sent a letter regarding the matter to the physician as well. Though there is no telling that everyone involved received these letters. 

I also have an Assurity MRI pacemaker, but it looks as though my implant date occurred after the dates they listed ( June 2019 for me), and the lot number wasn't on the list- it's a higher number than any on that list anyway. 

As you say, it's a watch and wait type scenario, in the rare event that a malfunction either in the leads or pacemaker occurs, or it stops transmitting, or suddenly reaches EOL this would be picked up within 24 hours ( according to the Abbott website) and the clinician ( pacer tech, whoever gets those urgent messages) would be notified emergently.

That should provide some reassurance, though if I were in that boat, whether or not I got the letter( and if I didn't, I'd assume most likely my doc/clinic didn't either), I'd do as you plan to do and contact them, if for no other reason than to make sure they are aware of the issue, and that MY pacemaker is one of those involved. And let them reassure me about what's to be done about it.

Pm 2272

by Finn - 2021-12-09 09:39:12

I just posted about this, I did not receive a letter also, I called Abbott and discussed it.

btw they added dates forward, my implant was April of 2019 and I'm on the list.

Letters

by Tracey_E - 2021-12-09 10:10:03

I did not get a letter. Abbott told me that the letter would come from my doctor. Their customer service is amazing, if you have questions email them. I got a response less than an hour later. 

what my doctor said

by Tracey_E - 2021-12-09 16:32:56

Heard back from my ep's office. They didn't bother sending me a notification because the only thing to do is send regular transmissions, which I already do and they aren't concerned about anything unusual happening. My battery has said 8 1/2 years remaining for 2 years now.

Recall letter

by Finn - 2021-12-20 12:18:26

The letter from Abbott through my Cardiologist is very interesting. I'd post it but don't know how to attach it.