NIM® EMG ELECTRODE
Received Sep 18, 2025 · Event occurred Aug 21, 2025
Report 1045254-2025-02157 · MDR key 23082078
Device
Generic name
Electrode, Needle
Manufacturer
Medtronic Xomed Inc.Model number
XOM UNK NIMELECTROCatalog number
XOM UNK NIMELECTRO
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6 : D1102 CODE UPDATED, PREVIOUSLY UPDATED D16 CODE NO LONGER APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED DURING SURGERY, THE SYSTEM WAS NOT GIVING A RESPONSE WHEN THE SURGEON STIMMED VIA THE PROBE. TROUBLESHOOTING WAS PERFORMED, SITE CONFIRMED THAT ELECTRODE CHECK HAS PASSED SUCCESSFULLY PRIOR TO CALL. TS HAD SITE FIRMLY TAP THE ELECTRODES ON THE PI BOX. SITE STATED THAT DESPITE FIRMLY TAPPING, THERE WAS NO RESPONSE ON THE NIM. TS SUGGESTED TO SITE THAT THE ELECTRODES COULD BE AT FAULT, AND THAT IF THE SURGEON WAS WILLING, THEY COULD BE RESEATED ON THE PATIENT. SITE ENDED THE CALL SHORTLY AFTER THIS SUGGESTION. PATIENT DEMOGRAPHICS AND SURGERY INFO NOT AVAILABLE AT THE TIME OF CALL. THERE WAS NO PATIENT IMPACT.