MalfunctionGWE
CASCADE EMG/EP/EEG IOM
Received Sep 15, 2016 · Event occurred Apr 28, 2016
Report 5952204 · MDR key 5952204
Device
Generic name
Stimulator, Photic, Evoked Response
Manufacturer
Cadwell Industries, Inc.Product problems
- Thermal Decomposition of Device
Patient
61 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
AT THE END OF THE SPINAL CASE, THE VENDOR NOTED BURNS AT THE SITES OF THE NEUROSTIMULATOR ELECTRODE PINS.