NIM-ECLIPSE® ELECTRODE
Received May 13, 2026 · Event occurred Apr 17, 2026
Report 1045254-2026-00664 · MDR key 25156902
Device
Generic name
Electrode, Needle
Manufacturer
Medtronic Xomed, IncModel number
DSN2299Catalog number
DSN2299
Lot number
250221003A
Product problems
- Use of Device Problem
- Component Missing
Patient
Not reported
- Needle Stick/Puncture
- No Clinical Signs, Symptoms or Conditions
Narrative
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 DURING USE, THE ELECTRODES WERE FAULTY. THERE WAS NO PATIENT INJURY.