On sept 18, 1998 an incident occurred in the operating room, which rptr feels should be brought to fda's attention.
Pt is a 38-year-old male with a long-standing history of medically intractable seizures.
Based on previous investigations and consensus agreement at a conference, the pt was deemed be a good candidate for implantation of vagal nerve stimulator.
This is an fda approved device mfg by cyberonics, which has been demonstrated effective in the treatment of medically intractable partial seizures.
The pt had been explained the risks and benefits of the procedure and had consented to surgery.
The procedure was performed on friday, september 18, 1998 in the afternoon under general anesthetic.
A left vagal nerve lead was placed over the vagus nerve, which had been clearly identified.
Before connecting the generator to the lead, the vagal nerve generator had passed a routine diagnostic test.
It was then attached to the vagal nerve lead, which was wrapped around the left vagus nerve.
The lead test was then performed.
This involves the generator stimulation of the vagus nerve.
As soon as the lead test was commenced, the pt became asystolic.
This test was aborted and the pt reverted to sinus rhythm.
The duration of asystole was approximately 10 seconds.
This was recorded by the anesthetist.
Interrogation of the device was performed by the neurophysiologist of the dept of neurology.
A nurse who was a rep of cyberonics was present at the time of the procedure.
A backup generator was then connected to the vagal nerve lead.
It's diagnostics as well were normal and when the lead test was performed, the pt's pulse did not change.
The initial generator then underwent a repeat diagnostic test, which again revealed the generator to be normal.
A lead test with the original generator was then repeated.
The pt again became briefly asystolic.
This test was immediately aborted.
At this point, a decision was made not to implant a stimulator in this pt given the unk etiology of this arrhythmia.
The vagal nerve lead was then removed from the vagus nerve.
The device was then put under the care of a dr, the dept of neurology and the nurse rep from the cyberonic's co.
The operative field was irrigated and closed.
General endotracheal anesthesia was reversed and the pt was examined and found to be neurologically normal.
His vital signs were stable.
He was maintained in a monitored setting overnight and was seen in consultation by an attending cardiologist, who concluded that his heart was normal.
A full or incident report was filed and submitted to the operating room.
Rptr has filed an oral report with the food and drug administration.
As well, rptr has contacted cyberonics concerning this incident and questioning implantation of the vagal nerve stimulator device.
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