NIM® EMG ELECTRODE

Description of Event or Problem

IT WAS REPORTED THAT DURING INSPIRE CASE, WHEN STIMMING NERVE GOT NO RESPONSE FROM THE NIM CONSOLE. THEY SWITCHED ON PI BOXES, WENT FROM WIRED TO WIRELESS. RESET THE MACHINE. AND STILL GOT NO RESPONSE. THEY THEN SWITCHED TO A NIM 3.0 AND STILL GOT NO RESPONSE. THERE WAS 10 MINUTES DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THE CASE ENDED AND THE PATIENT HAD NO INJURY. THE SYSTEM WAS WORKING FINE. THEY SWITCHED TO NIM 3.0 AND COMPLETED THE CASE. DURING TROUBLESHOOTING THEY ALSO SWITCHED OUT THE ELECTRODES WHICH HAD THE ISSUE. THEY DISCARDED THE OLD ELECTRODES AND CASE WAS COMPLETED WITH NO ISSUE.

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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.