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U.S. Department of Health and Human Services

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Type of Device:
stimulator, autonomic nerve, implanted for epilepsy
Device Brand Name:
vns lead
Device Manufacturer's Name:
Cyberonics, Inc
Date of this Report:
(mm/dd/yyyy)
11/23/2011
Describe the Event
or Problem:
Pt had a vagus nerve stimulator placed in approximately 2005 or 2006. Pt has a seizure disorder & hydrocephalus; traumatic birth. Pt recently had an increase in his frequency and type of seizures. Battery was interrogated by Dr. and found to be completely depleted of voltage. Pt presented here recently for generator replacement but we found that the lead was completely disconnected from the wires up in the neck. It appeared that there was fluid that filled the channel indicating that this was longstanding. The wound had been closed and the patient sent home for a week while we arranged for a time to bring him back to do the longer surgery were we need to explore the vagus nerve and scar tissue and remove his broken lead and place a new one. Surgery recently completed for this procedure: dissection made down to the scar to the platysma, which we freed up and undermined. Worked way through scar just medial to the sternocleidomastoid muscle and identified the broken wires protruding upward. There was one anchor that was holding this electrode, which is the reason that this fractured at this point. There was no strain release loop left in the neck. We released the anchor, divided the lead, and then followed the lead down towards the vagus nerve. The jugular vein was identified and freed up as was the carotid artery. We worked our way on the more proximal and where there was not as much scar tissue and came down to the vagus nerve. We then worked our way cranially up the vagus nerve and then along the wire with a 15 blade until we came to the junction of the wire in the vagus nerve. Under loupe magnification, able to release the scar over the lead and then unwind the lead from around the nerve. There was quite a bit of scar tissue around the nerve and we were not sure how well a new electrode would work so we made sure we had a long segment of nerve, especially with some on the more proximal end to accept the local lead. The wound was irrigated, new lead wrapped around the vagus nerve carefully so as not to touch the wires and as well as its anchor. Slight strain releasee inferiorly and then looped the thick end of the electrode upward and secured it in 2 places with anchors under the paracervical musculature. We made a pocket for upward loop of the electrode. Tunneler to pass electrode. Tested lead; impedances were all good. Generator was zeroed out and will have to be set by Dr. some time in future. Wounds irrigated, sutured. Pt to recovery in stable condition.
the device(s) may have
caused or contributed to:
Potential for patient harm
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