Medtronic Class I recall for dual chamber PM's

https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm631470.htm 

If you have not yet been notified by your physicians, contact your doctors if you have one of these devices. 

Grateful Heart


8 Comments

yikes

by Tracey_E - 2019-02-16 08:29:02

That's a big recall! But looks like it can be fixed with a software update, whew. Did you get a letter?

Lots of Recalls

by BarbD - 2019-02-16 10:09:40

I just looked at that link and saw all of the recalls since 2016 and there are a lot of them affecting hundreds of thousands of patients.  Another reason that I'm scared to death about getting a device :-(

 

Recall

by Grateful Heart - 2019-02-16 11:11:18

Tracey:  No, I didn't receive a letter....I get updates.  I have a Boston Scientific CRT-D

BarbD:  Like automobiles, it is a machine and can have recalls.  Like Tracey said, most likely software updates can fix issues.  Some of us are told not to come back for a year so when a recall occurs it is best not to wait the full year.

The idea is stay on top of it and be aware of possible issues.  Usually, you will receive a "patient letter" for a recall.  When there is a recall for a particular patient's device....I would call anyway....letter or not. 

None of us wanted a device but most of us wouldn't still be here without one.  The main thing is they can fix it.

Grateful Heart

BarbD ...... You are scared about the wrong thing

by IAN MC - 2019-02-16 13:16:07

Barbara.   You have sent a few posts expressing your fear about having a device but none expressing fears at having a faulty heart.

I don't know why the solution worries you more than the problem ?

Ian

IAN....I'm scared about everything!

by BarbD - 2019-02-16 22:12:07

I probably should be more worried about the heart issues, but it almost doesn't seem real since I feel absolutely fine right now. Up until now I haven't really felt like a "heart patient" and have probably been in denial, but ever since my EP recommended the device that's all I think about. I'm afraid that I'll be worried all the time about getting a shock, something going wrong with the leads, needing to replace the device every few years, frequent appts, and just not feeling good anymore. I worry about the surgery going wrong, radiation from the flouroscopy, leads perforating my heart, infections...etc etc   I'm seeing a therapist and trying meditation and CBT but nothing seems to help with the anxiety. 

Barb

by Grateful Heart - 2019-02-16 23:14:55

We understand.  I almost walked out of the hospital right before my implant.  I didn't like the whole idea.  I am so glad I didn't.  My conditions have improved tremendously.     

We could get hit by a car crossing the street....or in a terrible accident driving.

The only advice I can give you....since you are worrying about everything anyway....is get it done and then see how much better you feel.  Once you have the surgery behind you, you can move on with the rest of your life.  It sounds like you are stuck and only you can move yourself forward.

BTW, I had my last device for 10 years and have never been shocked.  I would be glad to try and help you in any way I can if you want to private message me.  Trust your doctor if he says you need a device...they are the experts.  Get a 2nd opinion if you need to be sure....I did that too.

Grateful Heart

you were such a help and support to me

by jessie - 2019-02-23 13:31:59

before i received my 3 lead medtronic. i had some heart failure felt horrid and wasnt sure of anything. it's been 2 years and i am so so much better. we are adjusting to liivng in a 55 and up building  and it was a good choice.it is a foundation actually within a church to begin with. st paul's outreach. we purchased a 2 bedroom 2 bathroom apt and we pay a fee monthly which is really low. it'ss really stress free when you consider no house now. the locations great and we are carefully acquiring new friends and closer to family and  old friends. i didnt in the end end up with a defib but you gave me tons of support. thank you thank you. again jessie

Jessie

by Grateful Heart - 2019-04-09 22:37:36

I'm glad you are doing so well now.  Stress free is a blessing!

Thank you for the kind words.

Grateful Heart

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