RECALL NEVER RECEIVED

Hi,

8 years ago I had a Bostin Scientific placed and it was the best thing ever.   I instantly felt better.  A few months a go I was asleep and was woken up with my chest and left arm jumping so hard you could see it across the room.   I called an ambulance and they could see my ekg was way off.  I was pacing before I should have been and out of rythym.   Went to the closest hospital and they said they had never seen anything like it.   They found a Bostin machine to try to connect and the machine couldn't find me.  Hours went by and Bostin finally admitted there was a recall on my pacemaker and it had went in to safe mode.   Safe mode normally would have been fine but mine was doing something rare with the jerking.   They finally decided to send me to the hospital had placed it with was an hour away so I was transported.  

They did not do the surgery until the next morning which by then I was at 32 hours of this non stop jerking and pouding and hearing the nurses over and over saying they never seen anything like this didn't help my nerves.

Also I had a sign that this was getting ready to happen witch was a twitch I had in my stomach for 3 weeks prior every single day.   When I read more about this weeks after my surgery that was one of the signs and it has not done it one time since the replacement.

They told me it was related to the battery getting ready to go out.   

I am writing here to warn others to look on sites to make sure you don't have a recall on your device because if I would have been warned about all of this the surgery could have been scheduled before hand and the fear of all that went on would not have happened.  Plus the fear that it may have damaged my heart.

Bostin Scientific plus my EP both let me down on this.

I also have a device at home that monitiors my pacemaker so I am still confused in how this all happened!  

The recall was that the devices were going in to safe mode about 2 years before they should have.   So mine should have been replaced last year.  They called for early replacement.

Again just a warning to all to watch for these things yourself!   I learned the hard way.

 

 

 

 

 

4 Comments

I check the FDA site from time to time

by crustyg - 2024-11-13 17:57:53

I expect there's an RSS feed for this but I just go to the FDA website from time to time and check:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

using Boston Sci simple PM LWP for the various categories and it takes me to recalls for my device family.

How interesting

by piglet22 - 2024-11-14 06:06:26

I don't have a Boston device, but your experience almost exactly mirrors mine.

What struck me at the time was that several medics and paramedics either said they hadn't seen it before or worse, that it couldn't happen.

I was on 3 monthly watch with nearly 11 years on a Medtronic pacemaker. One evening, the muscles over the device in my chest started twitching in time with my pulse and it soon spread to my left arm.

I called the ambulance and they were stumped. At the hospital reception, a senior ambulance paramedic said that a pacemaker didn't have the electrical power to activate muscles. So much for that advice.

To cut a long story short, just before midnight, an EP came in, interrogated the device and said that the battery had gone so low, the device has changed mode. She didn't mention safe mode.

She changed some settings to stop the twitching and next morning, the device was replaced. The pacing people were pretty apologetic, but clearly had left things too late.

I did a bit of research afterwards and found that some older devices used muscle twitching as an end of life alarm. For a cardiac device to activate muscles beyond the target muscle suggests that something about the generated pulse current path had changed. It wasn't a lead problem as I still have the original leads.

So there you are. Your experience was unusual but does happen.

I'm currently waiting for a date in January 2025 for another replacement and a little apprehensive about going through that again.

Home bedside monitors hadn't been commonly used then, so it was entirely dependent on hospital visits to determine replacements.

Either it caught them unawares or they were squeezing the last bit of power out of the battery. With nearly 11 years on the battery with a manufacturers projection of 9.2 years, I think they were pushing their luck. One of them said "we had you on our radar" You could have fooled me.

I can't blame the A&E people for being stumped or disbelieveing, but I do blame the hospital team for taking their eye off the ball.

Editted typing/auto correct mistakes 

piglet

by confused - 2024-11-14 11:08:17

Yes sounds like we had the same expierence for sure.  

 

Good luck on your replacement in a few months!!!  

I would be confused too

by PacedNRunning - 2024-11-14 21:49:41

I would be confused too.  Hopefully your EP has an explanation. I had the same device with a recall and was determined mine wasn't affected but my battery only lasted 5 years. They should have made you aware and only replace if you are high risk, meaning dependent on your device.  Maybe you aren't considered dependent and not qualiy for early replacement but they should have at least had you on their radar to watch closely!!!!  I would want to hear an explanation from my team because this is not cool. Glad you were ok!  Oh, the twitching is from the mode it's in when it goes into back up mode. Those modes tend to cause twitching.  

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