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 THE FIRST TIME CONSOLE WAS USED SINCE THE SOFTWARE UPGRADE TO 1.5.4 FROM 1.4.3, THERE WERE SOME ISSUES OCCURRING WITH THE INCREMENTING PROBE AND RECEIVING 'LEAD OFF DETECTED' WARNINGS DURING A TOTAL THYROIDECTOMY. FIRST, WHEN FIRST CONNECTING THE PI BOX VIA BLUETOOTH, A WARNING APPEARING ON THE NIM CONSOLE THAT THE BATTERY OF THE PI BOX COULD NOT BE DETECTED. NEXT, ABOUT 45 MIN-1HOUR AFTER THE FIRST INCISION, A VISUAL WARNING APPEARED ON THE CONSOLE "LEAD OFF DETECTED" ON CHANNEL 2. A 'CHECK ELECTRODE' TEST WAS PERFORMED. AN 'X' APPEARED IN THE GROUND RIGHT AWAY, WHILE ALL OTHER LEADS IN THE TEST WERE 'LOADING'. AFTER TURNING OFF THE ELECTRODE TEST, THE ¿LEAD OFF DETECTED WARNING¿ DISAPPEARED FOR 30SEC-1MIN AND APPEARED TO MONITOR AS NORMAL, BUT THEN WOULD REAPPEAR. THE GROUND AND CHANNEL 2 ELECTRODES ON THE PI BOX WERE UNPLUGGED AND REPLUGGED BACK IN. CHANNEL 2 ELECTRODES WERE SWITCHED ON THE PI BOX. ¿LEAD OFF DETECTED¿ WARNING STILL APPEARED ON THE CONSOLE. THE GROUND AND STIM RETURN ELECTRODES ON THE PATIENT'S SHOULDER APPEARED TO BE IN PLACE CORRECTLY WITH GOOD CONNECTION. ADDITIONALLY, DURING THIS PROCESS, IT WAS REALIZED THAT WHEN THE SURGEON ATTEMPTED TO STIM WITH THE INCREMENTING PROBE, NO CURRENT WAS BEING DELIVERED (NO STIMULUS APPEARING UNDER THE STIM LEVEL ON THE CONSOLE SCREEN). TRIED UNPLUGGING AND REPLUGGING THE STIM OUT PLUG ON THE PI BOX. THE SURGEON WAS ABLE TO DELIVER ONE STIMULUS RIGHT AFTER THIS, BUT THEN CONTINUED TO NOT DELIVER ANY STIMULUS. THIS TROUBLESHOOTING CYCLE HAPPENED 3-4 TIMES BEFORE THE CUSTOMER SWITCHED TO A NIM 3.0. UPON BOOTING UP, THE NIM 3 SHOWED ALL 4 ELECTRODES FAILING THE INITIAL IMPEDANCE TEST (VISUAL INSPECTION SHOWED EVERYTHING WAS CONNECTED AS IT SHOULD BE). THE NIM 3 WAS REBOOTED AND RECEIVED RED ¿X¿ ON VOCALIS RIGHT AND LEFT ELECTRODES, AND A GREEN ¿?¿ FOR STIM 1 RETURN AND GROUND ELECTRODES. LASTLY, THE GROUND AND STIM RETURN ELECTRODES WERE REPLACED BY A SET OF PAIRED SUBDERMAL GROUND AND STIM RETURN ELECTRODES WITH THE NIM 3 STILL IN USE. ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS INTERVENTION PERFORMED. NO CONSEQUENCES OR IMPACT TO PATIENT.

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.