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U.S. Department of Health and Human Services

Medsun Reports
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Type of Device:
STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Device Brand Name:
VNS Therapy Pulse
Device Manufacturer's Name:
CYBERONICS, INC.
Date of this Report:
(mm/dd/yyyy)
12/19/2014
Describe the Event
or Problem:
The patient is a white male with intractable epilepsy. One month ago the patient underwent removal of his vagal nerve simulator due to "pain," "burning," and discomfort. The device did not prevent/reduce seizure activity as intended. This particular generator and lead were implanted approximately three and a half years ago. Of note, the patient underwent vagal nerve stimulator implantation originally eight years ago. Of note, the patient initially underwent implantation of vagal nerve simulator which was removed and replaced three times due over the course of five years due to various reasons including pain, discomfort, infection and migration of device due to weight loss.
the device(s) may have
caused or contributed to:
Minor injury to the patient or health care provider
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