NIM® EMG ELECTRODE

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 INTRA-OPERATIVELY THE NIM VITAL FACIAL NERVE MONITORING REMAINED IN 'ELECTRODE CHECK' MODE INSTEAD OF MONITORING; THE ELECTRODE VERIFICATION STEP WAS NOT PROPERLY VALIDATED, INCOMPLETE LAUNCH OF THE MONITORING SYSTEM DURING SURGERY, MAKING IT NON-FUNCTIONAL. PATIENT HAD IMMEDIATE POST-OPERATIVE FACIAL PARALYSIS THAT WILL REQUIRE MEDICAL MONITORING AND ADDITIONAL EXAMINATIONS IN THE MEDIUM AND LONG TERM. ADDITIONAL INFORMATION RECEIVED STATING THAT EVENT OCCURRED DURING OTOLOGIC SURGERY. USER NEVER STIMULATED AND PROBE WAS NOT USED. THEY REMAINED ON ELECTRODE CONTROL THROUGHOUT THE SURGERY DUE TO INATTENTION AND FOR GOT TO CLICK ON MONITORING. THE ELECTRODE PLACEMENT WAS GOOD. THE NERVES WERE PLACED ON THE FACE TO MONITOR THE FACIAL NERVE. THE ELECTRODE CHECK PASSED (GREEN BOX). PROCEDURE COMPLETED WITHOUT NERVE MONITORING AS USER NEVER PRESSED ¿MONITORING¿.