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U.S. Department of Health and Human Services

Medsun Reports
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Type of Device:
lead, stimulation, Vagus nerve
Device Brand Name:
VNS Therapy
Device Manufacturer's Name:
Cyberonics, Inc
Date of this Report:
(mm/dd/yyyy)
10/31/2012
Describe the Event
or Problem:
Patient with vagal nerve stimulator and lead had complaints of electric like shock above the stimulator and over the pectoral region. It was suspected that the lead was malfunctioning and lead replacement was indicated. During the surgery, the stimulator was removed and tested and was functioning properly. The lead was inspected and fluid was observed within the sheath of the lead. The lead was removed except from the vagal nerve. A new lead was implanted.
the device(s) may have
caused or contributed to:
Potential for patient harm
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