I think overheating was not the root of the problem: An ICD battery is just too weak to cause such an electrical overheat that would disrupt an otherwise perfect, sealed casing.
I think the "overheating" was not electronic in nature (some kind of short circuit) but chemical, a consequence of fluid getting trough the already flawed (corroded?) seal of the casing.
This is clearly the work of the rebel white blood cell alliance. They really shouldn't build these things with vulnerable 2 micron exhaust ports. One lucky shot and boom, there goes the Death ICD.
Health Train Express - The case reports suggests he had had the device 4 weeks. The patient had received 5 inappropriate shocks for afib before the incident event. Reportedly, the patient demonstrated signs of pneumomediastinum and small pneumothorax as a result. The device was explanted within 5 hours after the event. An operative photo and CXR were included with the case report.
Hugo Campos -
I suppose there is a theoretic possibility that any manufacturer's ICD could do this if there were a flaw in manufacturing process or design of any one of a device's numerous components. Still, as far as I am aware, no other event like this has been reported anywhere in the world.
As a person of religious faith, I think I would rather die a peaceful and natural death than have somebody implant electrical gadgets and gizmos in my heart -- exploding ones or otherwise. "Frankenstein Medicine" is too much with us. Conscious life both pre-exists and post-exists this temporary flesh body. It's a fact we ought to learn.
In other words, the authors report extensively on the state of the exploded defebrillator, but not on patient outcome. (or whether he lost most of his pec!). To me, that's as scary as the exploding device.
I don't agree with religious objections to "frankenstein medicine" (all due respect), but I believe too many ICDs are implanted in too many people, and if this slows down the freight train, it may be a good thing.
Misuse of words will cause mass hysteria. The device did NOT "explode." Also it is an isolated incident. There are no other reports of a Biotronik device having the same occurence.
Before people scream "oh the humanity" or "I'll never get a Biotronik device or any other device" get all the facts.
The device did NOT "explode." Also it is an isolated incident. There are no other reports of a Biotronik device having the same occurence.
Before people scream "oh the humanity" or "I'll never get a Biotronik device or any other device" get all the facts.
I'm trying to get the facts, but none have been forthcoming. Please anony 10:20, do tell!
How do we explain the "marked deformity with doubling of the anteriorposterior diameter and the lateral V-shaped deformity" of the device housing and the "palpable subcutaneous emphysema bilaterally extending to the neck, throughout the left thoracic wall, and down the arm to the level of the elbow?" Are we to assume these findings were caused by the operator?
The author of this Case Study, Dr. Martin Hudec, has voluntarily requested that the case study be removed from Europace due to erroneous claims he made in the article, such as the device "exploding". The ICD did NOT explode. The can expanded, as has happened many times previously in ICDs from other manufacturers. Dr. Hudec also retracted the statement that this was his first experience of a battery overheating in the industry and added it was the first time he observed this happen from Biotronik. Europace has subsequently removed the article from their web site.
What made this event so "horrifying", "crazy", etc. is the fact that pictures accompanied the report. If this was just a written report, sans photo, the drama would be minimum.
Feel comfortable using Biotronik devices. They have the cleanest Product Performance Report in the industry. Biotronik prides themselves in doing more than required of them to assure safety and reliability.
Dr. Hudec's response by e-mail can be found in the comments section of my follow-up 'Defensive Blogging' post. Thanks for your info. Hopefully this will further clarify the circumstances surrounding the case's findings and the article's retraction from Europace.
Terrible event. Protect yourself, get an attorney and be pre-emptive, the company will consider you libelled them. At least get legal advice. I had a similar event 20 years ago regarding the improper use of a device, which I had reported.
22 comments:
OMG!!
Horrifying!
All I'm saying is that I do not see a Biotronik ICD in my future of replacement devices. EVER.
Wow that's crazy!!
I think overheating was not the root of the problem: An ICD battery is just too weak to cause such an electrical overheat that would disrupt an otherwise perfect, sealed casing.
I think the "overheating" was not electronic in nature (some kind of short circuit) but chemical, a consequence of fluid getting trough the already flawed (corroded?) seal of the casing.
So are you going to tell us the patient outcome? He was obviously injured -- hospitalized, & how long, etc?
This is clearly the work of the rebel white blood cell alliance. They really shouldn't build these things with vulnerable 2 micron exhaust ports. One lucky shot and boom, there goes the Death ICD.
Crazy.
How long had the device been present?
Is this possible with all ICDs or an unfortunate possibility only with the Biotronik Lumax?
Health Train Express -
The case reports suggests he had had the device 4 weeks. The patient had received 5 inappropriate shocks for afib before the incident event. Reportedly, the patient demonstrated signs of pneumomediastinum and small pneumothorax as a result. The device was explanted within 5 hours after the event. An operative photo and CXR were included with the case report.
Hugo Campos -
I suppose there is a theoretic possibility that any manufacturer's ICD could do this if there were a flaw in manufacturing process or design of any one of a device's numerous components. Still, as far as I am aware, no other event like this has been reported anywhere in the world.
Gerald -
The case report only states the device was explanted - not what happened to the patient.
That is how a third degree burn looks like. It is a special case since it happend "inside-out". This patient will probably lose most of his left pec.
As a person of religious faith, I think I would rather die a peaceful and natural death than have somebody implant electrical gadgets and gizmos in my heart -- exploding ones or otherwise. "Frankenstein Medicine" is too much with us. Conscious life both pre-exists and post-exists this temporary flesh body. It's a fact we ought to learn.
In other words, the authors report extensively on the state of the exploded defebrillator, but not on patient outcome. (or whether he lost most of his pec!). To me, that's as scary as the exploding device.
I don't agree with religious objections to "frankenstein medicine" (all due respect), but I believe too many ICDs are implanted in too many people, and if this slows down the freight train, it may be a good thing.
Thank you for the interesting link.
I know it's bad, but you had to know this was coming.
"That's the best blow job ever"
Ba dum bump.
Before this I never seen Biotronik ICD.Thanks for posting this information.Nice post!
Misuse of words will cause mass hysteria. The device did NOT "explode." Also it is an isolated incident. There are no other reports of a Biotronik device having the same occurence.
Before people scream "oh the humanity" or "I'll never get a Biotronik device or any other device" get all the facts.
Anony 10:20 AM:
The device did NOT "explode." Also it is an isolated incident. There are no other reports of a Biotronik device having the same occurence.
Before people scream "oh the humanity" or "I'll never get a Biotronik device or any other device" get all the facts.
I'm trying to get the facts, but none have been forthcoming. Please anony 10:20, do tell!
How do we explain the "marked deformity with doubling of the anteriorposterior diameter and the lateral V-shaped deformity" of the device housing and the "palpable subcutaneous emphysema bilaterally extending to the neck, throughout the left thoracic wall, and down the arm to the level of the elbow?" Are we to assume these findings were caused by the operator?
The author of this Case Study, Dr. Martin Hudec, has voluntarily requested that the case study be removed from Europace due to erroneous claims he made in the article, such as the device "exploding". The ICD did NOT explode. The can expanded, as has happened many times previously in ICDs from other manufacturers. Dr. Hudec also retracted the statement that this was his first experience of a battery overheating in the industry and added it was the first time he observed this happen from Biotronik. Europace has subsequently removed the article from their web site.
What made this event so "horrifying", "crazy", etc. is the fact that pictures accompanied the report. If this was just a written report, sans photo, the drama would be minimum.
Feel comfortable using Biotronik devices. They have the cleanest Product Performance Report in the industry. Biotronik prides themselves in doing more than required of them to assure safety and reliability.
Anony 11:26-
Thanks for this additional info. I hope to hear from an e-mail I sent Dr. Hudec to confirm.
Anony 11:26 -
Dr. Hudec's response by e-mail can be found in the comments section of my follow-up 'Defensive Blogging' post. Thanks for your info. Hopefully this will further clarify the circumstances surrounding the case's findings and the article's retraction from Europace.
http://translate.google.com/translate?js=y&prev=_t&hl=en&ie=UTF-8&layout=1&eotf=1&u=http%3A%2F%2Fwww.sukl.sk%2Fsk%2Fzdravotnicke-pomocky%2Foznamy%2Finformacia-o-nehode-poruche-zlyhani-implantovatelneho-defibrilatora-lumax-340-vr-t-od-vyrobcu-biotronik-se-co-kg-nemecko&sl=sk&tl=en
This report doesn't show the pictures but is a report nonetheless. Tis device was recalled in Slovakia why shouldn't it be recalled here?
Terrible event. Protect yourself, get an attorney and be pre-emptive, the company will consider you libelled them. At least get legal advice. I had a similar event 20 years ago regarding the improper use of a device, which I had reported.
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