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Post Info TOPIC: Implanted Biotronik pacemaker/defibrillator issues


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Date:
Implanted Biotronik pacemaker/defibrillator issues


Implanted Biotronik pacemaker/defibrillator issues

If you have a Biotronik device implanted I suggest you read this:
https://www.abc.net.au/news/2020-01-16/pacemaker-electric-shocks-woman-60-times-sparks-regulation-call/11855532

A brief precis of the above:
A woman's implanted defibrillator malfunctioned and issued 60
electrical shocks to her heart over a one hour or so period.
Apparently 15 shocks is normally enough to kill.

Over my 45+ years as an electronics/embedded systems engineer I have
written a lot of firmware (software) for critical devices; from laser
tools for eye surgery to military aircraft: all of those devices had
the potential to kill people if they malfunctioned so it was critical
the firmware was written with the utmost care and tested thoroughly.

Safety critical software needs to regularly and routinely test itself
as much as possible to ensure it is functioning correctly. It is not
possible for the software to test functionality to 100% but there is
a lot it can do. One of the most basic tests is a "Sanity check".
eg. Assume we're the navigation software in a 747 aircraft which took
off from Sydney 22 minutes ago and we send a message to the GPS
modules asking for our current position, the response informs us that
we are currently crossing the SE coast of Sri Lanka. Hang on a minute
says our sanity check code; Sri Lanka is 8500km from Sydney which
means this aircraft would have to be flying at 23182kph to have
covered that distance in 22 minutes... and it can't! This basic check
tells us the GPS module is broken and we should inform a human and
let them decide what to do.

Given that 15 shocks is generally enough to kill I would have thought
that after, say, 10 shocks the defibrillator software should be
saying... "Hang on a mo' - there may be a problem" rather than just
keep on shocking the patient until they die!

Put it this way: if I were fitted with a Biotronik pacemaker or
defibrillator I would be making an appointment with my cardiologist
ASAP and insisting up a replacement unit by another manufacturer or a
software upgrade in which the above issue has been rectified.

It is interesting this issue has not received wider publicity.



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"I beseech you in the bowels of Christ think it possible you may be mistaken"

Oliver Cromwell, 3rd August 1650 - in a letter to the General Assembly of the Kirk of Scotland



Guru

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Posts: 1143
Date:

Although I don't need to worry as I am not fitted with a jump start as yet, (I think my wife thinks I should be at times), this was very informative and interesting insight into a subject I hadn't thought about before. So thank you Mike.

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Greg O'Brien



Guru

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Posts: 1319
Date:

I read an article about this just after xmas, and informed a friend whom has a pacemaker, and he was unlucky/lucky to both be informed by me, but also to now know, he has one of these defective ones. He was not informed by his doctors or the manufacturers, his will be replaced on Monday, as the defect has been found in his. He thinks I may have saved his life. What gets me is, the manufacturers knew about the defect, but did not inform patients or their doctors by the time I informed him.

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Ric - The Eccentric One

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