Anybody Had an MRI with a RECALLED Abbott PM 2272

recalled pacemakers

by AgentX86 - 2023-03-15 14:36:23

A number of us have recalled pacemakers. Mine because of the potential of a bad capacitor. I'm dependent and have no escape rhythm so would be SOL if it completely failed. They've said that the problem is very rare an only "one patient has died" (reassuring).

My pacemaker has a low battery function that will detect a low battery condition well before things get critical. At that point it will call home and report the problem. Because I'm dependent, replacement is a priority or  maybe an emergency.

In short, there isn't a a lot that can be done at this point. It's really not something you can change. Just make sure it's monitored.

Glue?

by Penguin - 2023-03-15 15:41:09

I've been told that the device is vulnerable to moisture ingress due to a faulty manufacturing process. Perhaps that's where the glue comes in?

I can't answer your question about an MRI because I don't understand how the faulty  technology might affect an MRI (if at all). Abbott or your EP are the best source of advice and if I was in your shoes and worried about an MRI I would ask the EP to speak to Abbott and to then explain any risks to me in writing. I can't imagine that a big medical tech company like Abbott would provide you with false assurances in this situation or expose you to risk, especially with a product whose USP is that it is MRI safe.  They would have to be incredibly cautious in providing information to you if there was any perceived risk at all. 

Re: Your other post - You mention lowering PVARP in a previous post as the method used to remove AF which you endured for 14 months.  I may be wrong here, and no doubt somebody else on here will have better knowledge than me, but as far as I know PVARP is usually adjusted upwards (rather than downwards) when PMT (rather than AFib.) is detected. PMT = Pacemaker Mediated Tachycardia.

 Other posters on here, including me, have struggled with PMT induced by settings with Abbott / DDDR devices and have suspected AF only to find that it was in fact PMT.  Has your AF been confirmed? 

PMT episodes are usually noted on the pacemaker interrogation paperwork.  Do you have copies that you could check against?  It should also show whether PVARP was adjusted up or down if you compare the setting before it was adjusted with the date of the adjustment.  Changes to settings are usually shown in bold type.   

I'm not sure that I agree with you that this device is too complicated for techs to understand.  They have access to Abbott Reps for training purposes and technical advice and those guys know their product inside out.  The Assurity device has also been around for quite a while now and I understand that Abbott supply lots of pacemakers in the US. Therefore IMO not knowing isn't an adequate excuse for 14 months of symptoms if PMT was the cause.  

AF is another thing altogether. An undetected atrial arrhythmia can trigger PMT.  There is an AF suppression setting on the Assurity device. I can't tell you anything about it unfortunately, but it might be worth asking about it in another post or looking it up in your device manual.  Someone will know how these settings work and how effective they are. 

I hope you can get your issues with this device sorted. 

St. Jude PM 2272 Recall List

by Marybird - 2023-03-15 20:54:37

Poolboy, are you sure your pacemaker is on that recall list? I ask because I also have a St. Jude Assurity PM 2272, implanted in June 2019. I didn't get any letter, but of course was curious to see if my pacemaker was on that list. It was not, as I learned from reading the letter, information concerning the recall from both the Abbott and FDA websites, this recall affected pacemakers manufactured from around 2014 or 2015 through March of 2019. On the FDA site the affected pacemakers were listed by serial number and model ( ie, Assurity, Endurity) from low to high in succession. The serial number of my pacemaker was not on that list, in fact my serial number was higher than the highest serial number on the list, indicating, I assume, the pacemaker was manufactured after the problem was discovered. There was also a page on the Abbott website with information about this recall, showing the letter, links to the FDA sites, and also a place that allowed someone to input the serial number of his/ her St. Jude pacemaker to see if it was included in those recalled. I put in the serial number of my pacemaker, and received a response saying it was NOT included in the list of recalls.

I mention this as I'd think it's quite possible your pacemaker implanted in 2020 was manufactured after the problem causing the recall was discovered, and as such would not be involved in the recall. Unless you have already learned that your pacemaker is on the list, it might be worthwhile to find out for sure and dispel any concerns you may have about this. 

Heat build up from MRI

by crustyg - 2023-03-16 09:52:27

I'm not sure that the box itself will get much induced heating from an MRI - it's usually the leads that were or might have been an issue.

If you think about it, if the PM box itself were to heat up much during an MRI then if the heating were very significant then you'd slide out and get away from the MRI.  At least one contributor here (with a lead/PM combo that wasn't actually formally certified as MRI-compatible) *did* feel localised warming.  But let's be clear - it was warming.  Pretty much the same as sitting in hot tropical sunshine.  If it were as hot as 50C then it would cause tissue damage and you wouldn't stand for it.

So I think it's very unlikely that any warming might affect the integrity of a glued join.

Mri with recalled PM2272

by pooolboy - 2023-03-16 11:45:24

CrustyG thanks for the heat build up info.

MaryBird: Unfortunately my PM 2272 is definitely on the recall list.  I have a feeling that this old PM 2272 was on the shelf like the car that nobody wants on the car sales parking lot until the boss says, Get rid of that car, don't care what you sell it for..  I will never again allow anything like that be done to me again...I will TELL the doctor what brand and model to use or forget it.

during MRI, PM will be programed by the rep not EP and defibrillator function will be turned off.

by brady - 2023-03-16 18:08:06

I don’t have the same pacemaker as you do so not qualified to answer your question. But I just had a 3T MRI scan and would like to share my non professional and ignorant experience with you.

I am surprise that the pacemaker generator was glued together. Your concern is valid. I  believe the magnetic fields will not affect the glue. However, the RF pulse used in MRI is quite strong, 2-3 kilo watts outside and is 2-3Watts/kg inside the body.

The first thing I would check is if the pacemaker is “MRI conditional” that is approved by the FDA to do MRI without “harm” to the pm and patient. If it is MRI conditional, then this is the best guarantee that you will ever able to get.

If you don’t want other to reprogram your PM, then you are out of luck, because during MRI, your pm will be programed to one of the “MRI” modes. They are typically AOO, VOO, or DOO asynchronous mode. The PM will be re-programed back to the original mode after MRI scan.  The PM’s settings before and after MRI should be the same so I wouldn’t be concerned whether the Abbott tech or the EP programs it. The scan could take as long as one hour and your EP will most likely not be there.

If you have AFIB, I would be concerned, as I believe during MRI, the defibrillator function will be turned off.