ICD induced fatal vf

In searching for the adverse report event for my episode in the FDA Data Base I happened on to a very interesting adverse event posting by a manufacturers rep. He states that the low impedence of the lead "inapproiatly" induced the vf episode that eventuallly ended with the death of the patient. Its a very good explaination and "food for thought" for all of us. Just go to the FDA home site [http://www.fda.gov/search.html] and in the search box type in 687423. This is the report number. Its worth a read to anyone having vf episodes that has an ICD. I've had over 530 vf episodes in the last six months so I'm actively researching it. Anyone with any ideas would be greatly appreciated. Yes these things have saved lives in many cases, nut that doesn't help the ones who have lost loved ones to faulty units. Do your homework and thank God for the folks keeping this site going. Best of luck to all.
Kirby Knight

1 Comments

FDA Data Base

by ElectricFrank - 2008-06-14 01:06:48

Kirby,
Thanks for the heads up. The report is interesting and not too surprising.
The first thing that strikes me is that the patient seemed to be in bad condition to start with. The fact that the VF event occurred in a medical setting where external defib was available and used, yet the patient didn't regain consciousness would indicate that either defib was delayed to long or there were other issues that intervened. In either case it wasn't necessarily the ICD that was at fault. The lack of response to defib by the ICD would tend to confirm this.
By the way the "low impedance of the lead" is not a pacemaker or lead defect. The lead impedance is a measure of the contact with the heart wall. The low impedance could have been an indication that the electrode was embedded in damaged heart tissue, which precipitated the event.
We need to keep in mind that the ICD's or pacers we have are not magic. Like not kicking a dead horse, there comes a point where shocking a dead heart is not going to work.

As most know I am the first to point out the problems with poor programming and the dangers of ablation, but I would hate to see a helpful rep become more conservative for CYA purposes.

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