NIM® EMG ELECTRODE

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS FOUND THAT THE PACKAGING CARTON, BOTH INSERTS, AND THE DEVICE WERE RETURNED IN A PLASTIC BAG. THE DEVICE WAS PLACED IN A PLASTIC CONTAINER WHEN RETURNED. THERE WERE NO TRACES OF CONTAMINATION OBSERVED ON THE DEVICE. ELECTRICALLY, THE RESISTANCE FROM END TO END SHALL BE LESS THAN 2.0 OHMS. HOWEVER, DURING THE ELECTRICAL TEST, THERE WAS CONTINUITY OBSERVED BETWEEN BOTH POLES REGARDLESS OF WHICH END WAS BEING MEASURED (OPPOSITE POLES) RESULTING IN SHORT CIRCUIT. FOR FURTHER ANALYSIS, AN X-RAY WAS PERFORMED TO OBSERVE THE INTERNAL CONSTRUCTION OF THE NEEDLE HOUSING, AND IT WAS OBSERVED THAT THE WIRE FROM ONE POLE WAS TOUCHING THE NEEDLE HOUSING FROM THE OTHER POLE - SHORT CIRCUIT. THE COMPLAINT WAS CONFIRMED, DUE TO AN OUT OF SPECIFICATION CONDITION. 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 DURING MASTOIDECTOMY/EAR CASE, THE BLUE ELECTRODE WAS NOT WORKING AND HAD NO NERVE ACTIVITY ON SCREEN. THE ELECTRODE CHECK WAS NOT ABLE TO BE PERFORMED AS WELL. THE TEAM REPLACED THE ELECTRODE WITH A NEW PIECE AND IT WORKED WELL. THE STAFF OPENED ANOTHER PACK TO REPLACE THE AFFECTED ELECTRODE AND THE PROCEDURE WAS COMPLETED WITH IT. THE ELECTRODE WAS USED AFTER OPENING FROM THE SEALED PACKAGE AND THERE WAS NO DAMAGE NOTICED IN THE PACKAGING. THERE WAS NO PATIENT IMPACT.