MalfunctionGXZ
NIM® EMG ELECTRODE
Received Feb 24, 2022 · Event occurred Nov 19, 2021
Report 1045254-2022-00095 · MDR key 13590029
Device
Generic name
Electrode, Needle
Manufacturer
Medtronic Xomed Inc.Model number
XOM UNK NIMELECTROCatalog number
XOM UNK NIMELECTRO
Lot number
NI
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE ELECTRODE WAS FUNCTIONING WELL IMMEDIATELY PRE-OP, HOWEVER AT THE TIME OF STIMULATION OF THE NERVES, IT WOULD NOT RECORD A SIGNAL. THIS HAS HAPPENED FREQUENTLY. THERE WAS NO PATIENT IMPACT.