St. Jude Recall? ..scary

I am 100% paced and my device is 3 years old. My device was recalled because of possible moisture penetration. My battery went from 9.5 yrs to 3 months in a very short time. I had my device changed asap by St. Jude/Abott.. any one here go through a device failure or know of the protocol on this? My Merlin notified the Cardiologist  stat. All opinions appreciated 

 


8 Comments

Try to stay calm

by Gemita - 2022-02-05 04:09:27

Bergbennett,

I am assuming you are "awaiting" a replacement since your message is not entirely clear.  St. Jude/Abbott and your Pacemaker Clinic will no doubt continue to closely monitor you and replace your device asap and certainly before you experience troublesome symptoms. If you become symptomatic or have any questions, contact your cardiologist/EP immediately, but otherwise please try to stay calm.

I attach links that might be helpful to you and to other members potentially affected by this recall. 

You have been very unlucky since from recent posts, the vast majority with the same model, at least so far, have been unaffected and I hope it continues this way.  The most important thing to remember is that with home monitoring a close eye can be kept on you and your device and replacement arranged quickly if needed.

Good luck and stay safe

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

https://www.pacemakerclub.com/message/41581/pacemaker-recall-abbott

St Jude recall

by Finn - 2022-02-06 05:15:06

I posted before, my st Jude also included in the recall.

modell 2272, implanted April 2019 . Also 9.5 years remaining. 
I have a scheduled appointment coming and will discuss it. I'm told insurance will not cover a change out unless the battery becomes depleted. I will request to have St Jude cover the replacement.

I have Merlin also of course and I'm glad it alerted you.

Finn

by Gemita - 2022-02-06 06:23:10

I certainly hope St. Jude will cover the replacement for anyone affected and having difficulties before complete battery depletion. Hopefully though they will only watch in your case and replace it if and when needed?  I am assuming you have not been contacted to have your pacemaker replaced immediately?  Thank you for letting us know that your insurance will not cover a change out unless the battery becomes depleted.

Please update us after your next pacemaker appointment and let us know how things are.

Update.. St. Jude Recall

by bergbennett - 2022-02-06 18:42:22

I wasnt clear in my initial  post. My Merlin alerted my Elecro Cardiologist and I was called. They asked my condition and set an appointment for next morning. I met with St.Jude rep and Dr.. informed I had gone down to 1% battery life from 9.5 years. I was going to have surgical replacement that afternoon but O R rooms weren't available. I had the replacemt generator the following morning.I was informed verbally that st jude would pick up the cost..the defect was due to moisture entering the unit as best i was told. I am 100%  paced 70 yr old male. Home now feeling better than ever.  So far so good. Im just wondering if anyone had similar due to battery failure and not a telemetry recall issue. 

Thoughts? Please chime in

 

 

Recall

by AgentX86 - 2022-02-06 19:41:59

That's more clear. Yikes!  Several here have had the recall but no one has said they actually had the failure.  It was supposed to be a rare occurance.  I guess you're just lucky. I wouldn't be walking under ladders or have any black cats around anytime soon.

Finn

by Tracey_E - 2022-02-07 11:05:51

I asked my doctor about this. Those of us affected by the recall have had the devices for several years so if nothing has happened yet, odds are nothing will.  There have been fewer than 200 of the thousands implanted affected by the defect. If your Merlin is hooked up and checks in regularly, that's all you need to do. Merlin will alert them if anything changes. If we are affected by the recall, Abbott will pay for the replacement.

200 of the thousands

by AgentX86 - 2022-02-08 14:10:36

So far. Obviously they don't know how many more will be found. It's like an exeutive told us once "I want no more failures".  When gently told that that was impossible to know he continued "OK, then make sure any failures happen our systems!". "Yes, boss. Anything yu say boss."

From what BERGBENNETT's original post, it appears that  he has a defective unit and it has been replaced. That's #201.

ST. JUDE REACE

by bergbennett - 2022-02-08 16:02:25

I AM THE OP,  Yes.. i had my device replace within 24 hrs of diagnosis. Rep for the device was present. Verbally told me they would take care of the cost. Curious .. I was told by a (non involved tech) that there is compensation set aside and to google it. I have no idea. I believe im a needle in the Haystack with this issue. Anyone have any input?

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