APS¿ (AUTOMATIC PERIODIC STIMULATION) 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 DURING THYROID SURGERY WITH NERVASSURE PROCEDURE, ELECTRODE WAS CONNECTED WITH THE VAGUS NERVE, BUT IT WAS NOT DETECTED BY THE NEUROMONITOR NIM VITAL (LEAD NOT CONNECTED). SO USED ANOTHER APS-ELECTRODE AND WITH THAT EVERYTHING WAS WORKING PROPERLY. PROCEDURE WAS EXTENDED BUY 5 MINUTES. NO CONSEQUENCES OR IMPACT TO PATIENT.

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS FOUND THAT VISUALLY, THE C-CLIP CONTACT WAS NOT EXPOSED/FLUSH WITH THE INSIDE DIAMETER OF THE CLIP BODY WHEN RETURNED. THE CONTACT WAS RECESSED INSIDE THE CLIP BODY BY 0.03 INCHES (FROM THE CLIP OPENING TO THE DISTAL TIP OF THE CONTACT). THERE WERE TRACES OF CONTAMINATION AROUND THE OPENING OF THE CONTACT AREA OF THE CLIP BODY AND THE OUTSIDE DIAMETER OF THE BODY. ELECTRICALLY, FOR FURTHER ANALYSIS, THE RESISTANCE SHALL BE LESS THAN 25 OHMS END TO END AND THE ACTUAL MEASUREMENT WAS 11.5 OHMS WHICH WAS IN SPECIFICATION. IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. H6: ADDITIONAL INFORMATION SUGGEST THAT B17 , C20 AND D16 NO LONGER APPLY TO THIS EVENT. G2 : REPORT SOURCE HAS BEEN UPDATED. 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.