Device Recall...

Thanks for the heads-up

by Persephone - 2022-02-18 13:08:58

Thanks for sharing this information, Bob, and I hope you get it sorted out with your new EP soon.  As far as you can tell, does the recall drill down to production batches, serial numbers, or any other kind of distinction - or does it appear to be at only the model name / number level?

Recall

by AgentX86 - 2022-02-18 16:33:19

Your post prompted me to look up Medtronic recalls.  Yep, there was mine, recalled in May of 2019. It warned of catastrophic battery depletion because of a capacitor failure.  There are specific warnings about dependent patients and the importance of regular transmissions.  Also, a note to treat ERI as an emergency situation.

"Consider whether elective device replacement is warranted for any of your pacemaker patients due to pacemaker dependent status or other high-risk features." - IOW, me.

Score: 1-dead,1-dizzy and EP couldn't communicate with PM, and one wouldn't communicate before implant.

Nope, I wasn't told about this either. Wonderful.

Thanks.  You made my day.

Recalls

by WazzA - 2022-02-19 19:36:14

I understand that affected models recalled go down to Model No's & SERIAL No's. Mine was listed under Model Number BUT my Serial No was not included in the list published.

My EP/pacing team told me they will only contact patients who have one of those Serial No's are affected !

Recall

by AgentX86 - 2022-02-20 23:43:38

it looks like the Medtronic recall was for all CRT-Ps.  No serial numbers given.

"Although the devices may fail without tripping an elective replacement indicator (ERI), the alert says pacemaker-dependent patients who do get an ERI warning should be treated as a medical emergency."

In other words, the ERI might not be tripped.  Sucks to be you.

It's another "crcked capacitor" problem.  In my last job (in both senses of the word) we had strict rules for capacitors connected directly to the battery.  Their failure mode is a "short".  With a car battery, the result is a fire but a smaller battery may still discharge rapidly. I'd like to know what Medtronic's (all medical, really) rules are for such applications.  It seems that a failed capacitor shows up in recalls pretty regularly.

I like this... I was just playing around with the MHD app and hit the information icon on the battery life report and it says "For more information about the battery longevity, contact your clinic.  Limited Warranty Terms apply."

The battery longevity itself says "estimated as of 19-FEB-2018". Really useful.

EP only notifies if "urgent" or "immediate"....

by BOBTHOM - 2022-02-28 11:55:57

I finally heard back from my EP and the issue is quickly depleting battery as some noted in other comments.  They only notify patients if they see an issue.  Of course he then procedes to quote my battery life as of last November.  Not sure why he wouldn't quote the most recent interogation in Mid Feb or at least the last discharge in early Feb but it certainly does NOT make me feel comfortable in their abitly to monitor my device or manage recalls.

The sharing (or lack there of) of medical information across providers is unbeleivable. Even within the same group.  And it's not just cardio, I just had my hematologist tell me I had to have labs drawn at his office because if my GP draws them he won't see the results!  Just CRAZY!