NIM® EMG ELECTRODE

Additional Manufacturer Narrative

H6: PREVIOUSLY SUBMITTED CODE FDC D16 IS NO LONGER APPLICABLE. 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

ADDITIONAL INFORMATION RECEIVED THAT ONLY THE EMG TUBE AS HAVE USED THE OTHER EQUIPMENT SINCE AND THERE HAS BEEN NO ISSUES.

Additional Manufacturer Narrative

B5: ADDITIONAL INFORMATION RECEIVED. 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 WHEN THE EMG TUBE WAS PLACED BY THE ANESTHETIST AND THE PATIENT WAS DRAPED FOR THE LEFT THYROIDECTOMY WITH NERVE MONITORING PROCEDURE TO START, WHEN THE FIELD REP CONNECTED THE ELECTRODE TO THE MONITOR - NIM 3.0 AND ON THE PATIENT SIMULATOR AND THERE WAS AN ERROR ON THE SCREEN WHEN PERFORMED AN ELECTRODE CHECK - NEXT TO VOCALIS 1 AND VOCALIS 2 IT SHOWED 2 RED X ; TRIED TO TROUBLESHOOT THE MONITOR, THE PATIENT SIMULATOR, THE ELECTRODES, AND CHANGED THE FUSE ON THE PATIENT SIMULATOR BUT NOTHING WORKED. THE DOCTOR FINISHED THE PROCEDURE WITH THE EMG TUBE BUT THE NERVE MONITORING DID NOT TAKE PLACE AND THE PROCEDURE GOT DELAYED BY 10 MINUTES. THERE WAS NO PATIENT INJURY. THE DOCTOR MENTIONED ON THE PATIENT FOLLOW UP THAT THE NERVE WAS INTACT AND EVERYTHING WAS FINE WITH THE 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.