MalfunctionGXE
NICOLET SUBDERMAL NEEDLE
Received Jun 28, 1996 · Event occurred Feb 20, 1996
Report 35467 · MDR key 35467
Device
Generic name
Subdermal Needle
Manufacturer
Nicolet Biomedical, Inc.Model number
*Catalog number
019-404100
Lot number
*
Product problems
- Break
Patient
67 YR
- Surgery, prolonged
Narrative
Description of Event or Problem
ON 2/20/96 PT UNDERGOING POSTERIOR LUMBARSPINE DECOMPRESSION, FUSION AND INSTRUMENTATION HAD A STERILE SUBDERMAL RECORDING ELECTRODE PLACED IN THE LEFT VASTUS LATERALIS MUSCLE BY THE SPINE FELLOW. LARGE AMOUNTS OF ELECTRICAL NOISE PROMPTED THE NEUROPHYSIOLOGY TECHNOLOGIST TO CHECK THE SITE. THE NEEDLE HAD SEPARATED FROM SITE. THE NEEDLE HAD SEPARATED FROM THE WIRE. NEEDLE WAS VISUALIZED ON SUBSEQUENT AP & LATERAL FILMS. FOLLOWING COMPLETION OF THE CASE AN UNSUCCESSFUL ATTEMPT WAS MADE TO REMOVE THE NEEDLE FROM THE MUSCLE.