VF sensing question

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Anonymous

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I have a pt that has the newer Biotronik ICD. He has a history of VF with appropriate shocks. Every single episode we have reviewed, including the DFT induction test, there is a period of 5-7seconds where the device does not sense the arrhythmia. It is actually pacing during this time, and then the marker channels come in, and the device responds appropriately. What is the device doing during this time? Is there a blanking period with this device and if so what's the point of it? It delays the charge from what I can tell. The device is hooked up to boston scientific leads if that helps. The device is also programmed most sensitive and is a dual chamber device.

Has anybody else experienced this?
 






Anonymous said:
I have a pt that has the newer Biotronik ICD. He has a history of VF with appropriate shocks. Every single episode we have reviewed, including the DFT induction test, there is a period of 5-7seconds where the device does not sense the arrhythmia. It is actually pacing during this time, and then the marker channels come in, and the device responds appropriately. What is the device doing during this time? Is there a blanking period with this device and if so what's the point of it? It delays the charge from what I can tell. The device is hooked up to boston scientific leads if that helps. The device is also programmed most sensitive and is a dual chamber device.

Has anybody else experienced this?
Click to expand...

good luck to your patient if cafe pharma is where you go for tech services. trolling dope
 






Anonymous said:
I have a pt that has the newer Biotronik ICD. He has a history of VF with appropriate shocks. Every single episode we have reviewed, including the DFT induction test, there is a period of 5-7seconds where the device does not sense the arrhythmia. It is actually pacing during this time, and then the marker channels come in, and the device responds appropriately. What is the device doing during this time? Is there a blanking period with this device and if so what's the point of it? It delays the charge from what I can tell. The device is hooked up to boston scientific leads if that helps. The device is also programmed most sensitive and is a dual chamber device.

Has anybody else experienced this?
Click to expand...

Yea this is what happens next
http://cardiobrief.org/2010/10/09/the-plot-thickens-in-the-case-of-the-exploding-icd/
 






If its not sensing then its undersensing.... No? This also answers why you would see pacing...no? Maybe the pt needs a device with lower sensing capabilities or revise lead position.
 






Anonymous said:
If its not sensing then its undersensing.... No? This also answers why you would see pacing...no? Maybe the pt needs a device with lower sensing capabilities or revise lead position.
Click to expand...

It's certainly under sensing, but it consistently does it for 5-7 seconds only at the onset of the VF. The amplitude of the VF doesn't change.
 






Anonymous said:
It's certainly under sensing, but it consistently does it for 5-7 seconds only at the onset of the VF. The amplitude of the VF doesn't change.
Click to expand...

So what ends up being the total time to therapy measured from onset of the arrythmia (as you see it per the electrogram)? (5-7 seconds + 40J charge and shock = x seconds)

If you are concerned about the patient's total "time to therapy", you can shave a second off by ensuring the ATP OneShot feature is disabled (ATP in VF Zone) until such a time that a more permanent solution is found.

The Endotak is an integrated bipolar sensing configuration, but having worked at both BSX and BIO - I never felt like that caused the lead to undersense as some suggested. I only mention it because someone may bring it up as a culprit.

So was this a changeout from an old BSX system where the chronic Endotak was connected to a new Lumax, or was it a "hybrid" implant featuring a new BIO can connected to a newly implanted Endotak?

You say this happened during DFTs as well? Was any thought given to repositioning the lead at that point? Perhaps calling tech services or opening another can? I mean, I know this is Monday Morning Quarterbacking....but if this anomaly was noted on Day 1....

When you say it is programmed for maximum sensitivity...you are referring to the Enhanced VF Sensing feature, yes?

You definitely need to get Tech Services involved. There are some programming alternatives that they can walk you through that involve release codes only they know.
 






Anonymous said:
Yea this is what happens next
http://cardiobrief.org/2010/10/09/the-plot-thickens-in-the-case-of-the-exploding-icd/
Click to expand...

Hey guess fucking what?!?!?!?!?!?!?!?

Biotronik had ONE reported instance of a mysterious can exploding or venting..... ONE.

What about the 11,000+ 'hot can' issue that MDT had around 2005/6? Yes, MDT did a great job and got out in front of it and handled it. They pulled out over 10,000 cans in about 6 months but it was a serious issue and they knew it. There were reports all over the country of patients coming in the hospitals and offices with hot pockets.

What about the 100,000 + Sprint Fidellis leads??????

What about the endless Dear Doctors from BSX over the past few years?????

So, what's your point with the one reported case from 2010?
 






Anonymous said:
Hey guess fucking what?!?!?!?!?!?!?!?

Biotronik had ONE reported instance of a mysterious can exploding or venting..... ONE.

What about the 11,000+ 'hot can' issue that MDT had around 2005/6? Yes, MDT did a great job and got out in front of it and handled it. They pulled out over 10,000 cans in about 6 months but it was a serious issue and they knew it. There were reports all over the country of patients coming in the hospitals and offices with hot pockets.

What about the 100,000 + Sprint Fidellis leads??????

What about the endless Dear Doctors from BSX over the past few years?????

So, what's your point with the one reported case from 2010?
Click to expand...

Give it up, man, these maniacs are just going to come back with the "One can is 20% of your total implant volume, right?" Or the, "You guys are so crooked with yow you get your implants, why should we believe you are any less crooked when it comes to reporting?"

The hyocrisy is fantastic.
 






I had an EP tell me the same thing. He was doing a BTK changeout (because they were not on contract at this hospital for de novo) and during VF induction the device did not sense and the patient was externally shocked 2 times. The BTK rep called tech services but they could not resolve the issue so the EP took a MDT can off the shelf, hooked it up and worked fine the 1st time. I don't work for MDT, but this hospital had their product on the shelf so it was an easy fix. EP never heard back from BTK.
 






Would like to cross reference that serial number to a Maude report. Bet that it was never reported. When all you hire is cast offs and malcontents you don't exactly full your field staff with the cream off the crop. Meaning they either came from the generation that doesn't know compliance or a group that thumbs their now at compliance. Either way, their compliance department is a joke.
 






Anonymous said:
I have a pt that has the newer Biotronik ICD. He has a history of VF with appropriate shocks. Every single episode we have reviewed, including the DFT induction test, there is a period of 5-7seconds where the device does not sense the arrhythmia. It is actually pacing during this time, and then the marker channels come in, and the device responds appropriately. What is the device doing during this time? Is there a blanking period with this device and if so what's the point of it? It delays the charge from what I can tell. The device is hooked up to boston scientific leads if that helps. The device is also programmed most sensitive and is a dual chamber device.

Has anybody else experienced this?
Click to expand...

Report it to FDA. Report everything directly. Bio will not.
 






UPDATE:: I spoke with their tech services...apparently it's a known issue and they are rapidly working on a solution. I asked what kind of solution and they wouldn't tell me anything further. He knew what I was talking about when he found out it was an integrated lead though, apparently that is the problem...it confuses the device temporarily. Thanks to those that actually gave thoughtful responses.
 






Anonymous said:
UPDATE:: I spoke with their tech services...apparently it's a known issue and they are rapidly working on a solution. I asked what kind of solution and they wouldn't tell me anything further. He knew what I was talking about when he found out it was an integrated lead though, apparently that is the problem...it confuses the device temporarily. Thanks to those that actually gave thoughtful responses.
Click to expand...

Complete BS!
 






Anonymous said:
UPDATE:: I spoke with their tech services...apparently it's a known issue and they are rapidly working on a solution. I asked what kind of solution and they wouldn't tell me anything further. He knew what I was talking about when he found out it was an integrated lead though, apparently that is the problem...it confuses the device temporarily. Thanks to those that actually gave thoughtful responses.
Click to expand...

So did you report it to the FDA?
http://www.fda.gov/Safety/MedWatch/HowtoReport/default.htm
 






Anonymous said:
So what ends up being the total time to therapy measured from onset of the arrythmia (as you see it per the electrogram)? (5-7 seconds + 40J charge and shock = x seconds)

If you are concerned about the patient's total "time to therapy", you can shave a second off by ensuring the ATP OneShot feature is disabled (ATP in VF Zone) until such a time that a more permanent solution is found.

The Endotak is an integrated bipolar sensing configuration, but having worked at both BSX and BIO - I never felt like that caused the lead to undersense as some suggested. I only mention it because someone may bring it up as a culprit.

So was this a changeout from an old BSX system where the chronic Endotak was connected to a new Lumax, or was it a "hybrid" implant featuring a new BIO can connected to a newly implanted Endotak?

You say this happened during DFTs as well? Was any thought given to repositioning the lead at that point? Perhaps calling tech services or opening another can? I mean, I know this is Monday Morning Quarterbacking....but if this anomaly was noted on Day 1....

When you say it is programmed for maximum sensitivity...you are referring to the Enhanced VF Sensing feature, yes?

You definitely need to get Tech Services involved. There are some programming alternatives that they can walk you through that involve release codes only they know.
Click to expand...

Regardless of device or company there are other posibilities;

-What is the most sensitive setting in this device? Possible fine VF at onset may not be detected until deflections increase.
- If DFT is done in the least sensitive setting it is very possible the device doesn't see fine vf. Have rescued many pt's externally with all devices.
- Are you sure it was vf not slow vt below the detection rate zone therefore not picking it up until it accelerates?

This appears to be noticed only during DFT's since the device isn't going to store an event it doesn't see..I bet this is nothing more than the way the device was set up for DFT.
 


















Anonymous said:
Hey guess fucking what?!?!?!?!?!?!?!?

Biotronik had ONE reported instance of a mysterious can exploding or venting..... ONE.

What about the 11,000+ 'hot can' issue that MDT had around 2005/6? Yes, MDT did a great job and got out in front of it and handled it. They pulled out over 10,000 cans in about 6 months but it was a serious issue and they knew it. There were reports all over the country of patients coming in the hospitals and offices with hot pockets.

What about the 100,000 + Sprint Fidellis leads??????

What about the endless Dear Doctors from BSX over the past few years?????

So, what's your point with the one reported case from 2010?
Click to expand...

"REPORTED" is the operative word in the O.P. above.
LOL
 






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