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

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE AFTER UPDATING THE SOFTWARE TO 1.7.5 AFTER STIMULATING THE N. VAGUS WITH THE HAND PROBE THE APS ELECTRODE IS PLACED. WHILE THE PROCEDURE IS TAKING ON THE APS PROBE STOPS TO STIMULATE FROM TIME TO TIME FOR 4-5 SECONDS, IT IS LIKE THE SIGNAL IS SHUT DOWN DUE TO ARTEFACTS BUT THERE IS NOTHING COULD CAUSE ARTEFACTS IN THIS SPECIAL MOMENTS. THE APS VALUE WAS ABOUT 600UV AND 280UM AND THEN PAUSED WITHOUT A REASON FOR 4-5 SECONDS, THE SIGNAL DID NOT FALL IN IT INTENSITY. THERE WAS NO DELIVERY TONE HEARD WHEN STIMULATING AND NO WAVEFORM DISPLAYED. THE PROCEDURE WAS COMPLETED BY REPORTED PRODUCTS. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

H6: CODE IS UPDATED. PREVIOUSLY UPDATED FDC D16 IS NO MORE APPLICABLE. 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.