NIM® EMG ELECTRODE

Additional Manufacturer Narrative

THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 MASTOIDECTOMY, THE ISSUE WITH THE NIM MONITOR WAS THAT IT WAS ONLY INTERMITTENTLY RESPONDING. IT SEEMED TO HAVE TROUBLE REGISTERING. IT SHOULD MAKE A NOISE WHEN WE TOUCH TISSUE, WHETHER IT IS NERVE OR NOT, BUT IT WAS NOT CONSISTENTLY DOING THAT. IN ADDITION, EVEN WHEN PUTTING THE NERVE STIMULATOR ON THE FACIAL NERVE, WHICH WAS COMPLETELY DEHISCENT, IT OFTEN JUST GAVE US A TRACING BUT DID NOT MAKE ANY NOISE. ALSO, SOMETIMES THERE WAS NO RESPONSE, AND WHEN TRIED AGAIN LATER, AFTER A MINUTE OR SO, THERE WAS, WHICH IS CONCERNING. THERE WAS A DELAY OF 10 MINUTES, AND THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT.