NIM® EMG ELECTRODE

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.

Description of Event or Problem

IT WAS REPORTED THAT INTRA-OP, THERE WERE DIFFICULTIES CONNECTING THE BOX, WITH MESSAGES SUCH AS INTERFACE DISCONNECTED, REQUIRING THE SYSTEM TO BE PLUGGED IN AND UNPLUGGED SEVERAL TIMES TO ACHIEVE A FUNCTIONAL CONNECTION. WIRELESS ISSUES. SPONTANEOUS AND CONTINUOUS NERVE STIMULATION WHEN THE STYLUS IS NOT IN USE AND THE PATIENT IS PROPERLY ANESTHETIZED, MAKING THE USE OF NIM VERY COMPLICATED. ARTIFACTS ON NIM DURING PAROTIDECTOMY. 2 OR 3 TIMES THE SCREEN ¿FREEZED¿ DURING SETTINGS. PROCEDURE COMPLETED WITH SAME NIM. THERE WAS NO PATIENT IMPACT.