NIM® EMG ELECTRODE

Description of Event or Problem

IT WAS REPORTED THAT DURING MASTOIDECTOMY PROCEDURE, AFTER ANESTHESIA HAD TROUBLE KEEPING PATIENT ASLEEP AND WAS REPORTED THAT THE NIM WAS MAKING A LOT OF NOISE WHILE THEY WERE TROUBLESHOOTING ANESTHESIA (LOTS OF EVENT TONES). AFTER TALKING TO THE SURGEON AFTER THE FACT, THEY NOTED THAT AS THEY WERE TROUBLESHOOTING ANESTHESIA, THEY REPLACED THE NEEDLE ELECTRODES TO SEE IF THAT WOULD FIX THE NIM NOISE PROBLEM AND IT DID RESOLVE. ELECTRODE WORKED AT FIRST, THEN ANESTHESIA HAD TROUBLE KEEPING PATIENT ASLEEP, THEN ISSUE OCCURRED. HOWEVER, THE PROCEDURE WAS ABORTED DUE TO ANESTHESIA PROBLEMS. THERE WAS NO PATIENT IMPACT.

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.