Type of Device: |
lead, stimulation, Vagus nerve |
|
Device Brand Name: |
|
Device Manufacturer's Name: |
|
Date of this Report: (mm/dd/yyyy) |
|
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 |
|