Model Number 304-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 05/30/2014 |
Event Type
Injury
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Event Description
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It was reported that ever since initial implant, the patient experienced constant ear pain that was worse during stimulation.In the past, the physician tried reducing the settings but the pain did not resolve.The patient suspected the pain was related to the placement of the lead wire and desired a full revision surgery.The surgeon opted only to replace the generator, stating the cause of the pain in the ear could not be confirmed.It was recommended that the patient see the original surgeon who implanted the lead.It was also noted that the patient has allergies and recently was in a car accident, which may be related to the ear pain.Attempts for additional info have been made; no additional relevant info has been received to date.No further surgical intervention has occurred to date.
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Event Description
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Information was received indicating that the patient had been seen by an ent, who assessed that the lead may have been initially implanted too high on the vagus nerve, or that the electrode coils were not appropriately sized for the patient.The ent also recommended a lead repositioning surgery.No additional relevant information has been received to date.No known surgical intervention has occurred to date.
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Event Description
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The patient underwent lead revision surgery due to the reported ear pain.During the surgery, it was identified that there was inadequate strain relief on the lead and the strain relief was in the wrong location.The surgeon also noted that the electrodes were too high on the nerve, and the electrode diameter was too narrow for the patient's vagus nerve.The lead was replaced and was confirmed to have a better fit around the nerve.The explanted lead has not been received by the manufacturer to date.No additional relevant information has been received to date.
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Event Description
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Patient had full replacement due to jaw and ear pain.At first it was mostly during stimulation he said, but then it became constant.Immediately after the operation, the patient said he felt no more ear pain or jaw pain.
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Search Alerts/Recalls
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