NIM® EMG ELECTRODE

Description of Event or Problem

IT AS REPORTED THAT DURING A MASTOIDECTOMY CASE, THE SURGEON NOTICED INITIAL STIMULATION WHEN USING THE MONOPOLAR PROBE, BUT DID NOT HEARD ANY AUDITORY 'BEEPING' WHEN STIMULATING THE FACIAL NERVE. THE FACIAL NERVE WAS STILL UNDER BONE. BIOMEDICAL ENGINEERING TESTED THE CONSOLE AND PATIENT INTERFACE DURING THE PROCEDURE USING THE PATIENT SIMULATOR AND ANOTHER PROBE, AND THE SYSTEM TESTED NORMALLY. DURING THE PROCEDURE, THE SURGEON WAS STIMULATING AT 0.8MA, AND INCREASED TO 1.0MA AND TRIED TO RE-STIMULATE. NO RESPONSE, OTHER THAN SOMETHING FAINT, WAS NOTICED ON THE NIM-VITAL MONITOR. ELECTRODES WERE CHECKED TO ENSURE THEY WERE RESPONDING. ELECTRODE CHECK PERFORMED. NO RESPONSES ON MONITOR ABOVE EVENT THRESHOLD WERE ELICITED. 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.