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 DURING OTOLOGY PROCEDURE, THE ELECTRODE WAS PLACED IN PATIENT BUT IT DOES NOT RESPOND WHEN TAPPING AROUND THE ELECTRODE. REPOSITIONING DID NOT RESOLVE THE SITUATION. THE PROCEDURE WAS COMPLETED WITH BACKUP ELECTRODE. THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS FOUND THAT THE DEVICE (BLUE ELECTRODE) WAS PLACED IN A SMALL RESEALABLE BAG AND RETURNED IN A LARGE WHITE ENVELOPE. THERE WAS NO DAMAGE NOTED (EXTERNAL) IN THE CONSTRUCTION OF THE RETURNED ELECTRODE. THE NEEDLES WERE WRAPPED WITH A SURGICAL TAPE AND THERE WAS A STICKY RESIDUE FOUND ON THE NEEDLES. ELECTRICALLY, THE RESISTANCE FROM END TO END SHALL BE LESS THAN 2.0 OHMS AND THERE WAS CONTINUITY BETWEEN BOTH POLES REGARDLESS OF WHICH END WAS BEING MEASURED (OPPOSITE POLES) ¿ SHORT CIRCUIT. FOR FURTHER ANALYSIS, AN X-RAY WAS PERFORMED TO OBSERVE THE INTERNAL CONSTRUCTION OF THE RETURNED DEVICE, AND IT WAS OBSERVED THAT INSIDE THE NEEDLE HOUSING, THE WIRE FROM ONE POLE WAS TOUCHING THE WIRE FROM THE OTHER POLE CREATING ELECTRICAL SHORT CIRCUIT. THE COMPLAINT WAS CONFIRMED, DUE TO AN OUT OF SPECIFICATION CONDITION. H6: PREVIOUSLY APPLIED CODES FDM B17, FDR C20 AND FDC D16 ARE NO LONGER APPLICABLE. CORRECTION IN G2: REPORT SOURCE HAS BEEN SELECTED AS FOREIGN. 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.