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 INSPIRE SLEEP APNEA PROCEDURE/IMPLANT, THE PATIENT WAS DRAPED AT 12:39. THE ELECTRODES STARTED MAKING UNUSUAL NOISE WITH RESPONSES ON BOTH RED AND BLUE CHANNELS EXCEEDING 20,000 V. ANOTHER ELECTRODE CHECK WAS PERFORMED, WHICH STOPPED THE NOISE FOR ABOUT 3 MINUTES. HOWEVER, THE NOISE RESUMED, SO BOTH THE BLUE AND RED ELECTRODES WERE INVERTED TO SEE IF THE ISSUE WOULD STOP FOR A LONGER PERIOD. AFTER ANOTHER 3-5 MINUTES, THE NOISE STARTED AGAIN. THIS TIME, ONLY THE RED ELECTRODE WAS INVERTED, AND THE GREEN/GROUND WIRE WAS REMOVED FOR 2 FULL SECONDS BEFORE PLUGGING IT BACK IN. BY 12:47, THE NOISE RESUMED, BUT PROPER RESPONSES FOR THE PLACEMENT OF THE INSPIRE IMPLANT HAD ALREADY BEEN OBTAINED, SO IT WAS LEFT ALONE. THE PI BOX "WIRELESS" AND THE "WIRED MUTING CORD" WERE USED. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT, AND THERE WAS NO PATIENT IMPACT.