NIM® EMG ELECTRODE
Received Dec 16, 2025 · Event occurred Nov 19, 2025
Report 9612501-2025-03347 · MDR key 23818832
Device
Generic name
Electrode, Needle
Manufacturer
Medtronic DominicanaModel number
8227410Catalog number
8227410
Lot number
0231957465
Product problems
- False Negative Result
- False Negative Result
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6: PREVIOUSLY APPLIED CODES OF IMDRF ANNEX D: D16, ANNEX E: E2401 AND ANNEX F: F24 ARE NO LONGER APPLICABLE. CORRECTION IN H6: PREVIOUSLY REPORTED CODE OF IMDRF ANNEX B: B17 WAS NOT INCORRECT AND NOW IT HAS BEEN UPDATED. 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
ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.
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 THAT WHILE USING 2-CHANNEL SUBDERMAL ELECTRODES, THE RED CABLE MALFUNCTIONED. THE ELECTRODE WAS PLACED SUBDERMALLY, AND ALTHOUGH THE ELECTRODES WERE READING "OK," THERE WAS NO RESPONSE DURING TESTING. REPOSITIONING DID NOT RESOLVE THE ISSUE. AFTER REPLACING THE BOX AND USING A DIFFERENT CABLE, EVERYTHING WORKED FINE. THERE WAS NO KNOWN PATIENT IMPACT.