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 TYMPANIC MASTOIDECTOMY PROCEDURE, AFTER THE TOUCH TEST CARRIED OUT BY BOTH THE TECHNICIAN AND THE DOCTOR THE SET OF ELECTRODES FAILED TO COMMUNICATE WITH NIM MAINFRAME. STIM RETURN SHOWED "0" INDICATING THAT THERE WAS NO CURRENT BEING DELIVERED AND NO WAVEFORM DISPLAYED. A NEW SET OF ELECTRODES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY AND NO INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT IMPACT.