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 DURING AN OTOLOGY CASE USING FACIAL NERVE MONITORING. NIM VITAL WAS SET UP TO BE USED. THE SURGEON HAD JUST MADE AN INCISION USING A SCALPEL THEN WANTED TO STIMULATE ON THE FACIAL NERVE. 0.8MA WAS USED TO STIMULATE BUT THERE WAS NO CURRENT DELIVERY. INCREASED TO 1.5MA TO 2MA BUT STILL THERE WAS NO CURRENT DELIVERY. COULD NOT DO STIMULATION. MEDTRONIC EMPLOYEES WERE PRESENT AT THE TIME. THE STIM WAS SWITCHED- THERE STILL WAS NO CURRENT DELIVERY DESPITE THE SURGEON TRYING TO STIMULATE. SURGEON REQUESTED TO SWITCH TO THE NIM3.0. ONCE SET UP- EVERYTHING WORKED FINE AND WAS ABLE TO STIMULATE WITH NO ISSUES. THERE WAS NO PATIENT IMPACT AND LESS THAN 5 MINS DELAY TO THE PROCEDURE. SURGEON INDICATED THAT THERE HAS BEEN INTERMITTENT BEHAVIOR WITH NIM VITAL BEFORE. ONCE THE NIM3.0 WAS SET UP AND WORKED PROPERLY, MDT TEAM TRIED TO REPLICATE THE ISSUE IN THE OR (ON A CORNER) USING A PATIENT SIMULATOR HOWEVER THE VITAL SYSTEM WORKED WITH NO ISSUES. THERE WAS A CUT OBSERVED ON THE PI CABLE. THE PI, PI CABLE, STIM PROBE AND ELECTRODES USED IN THE CASE ARE PACKED UP TO BE SHIPPED BACK TO JACKSONVILLE. NO PATIENT IMPACT.