APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Additional Manufacturer Narrative

H3:PRODUCT ANALYSIS CONFIRMED VISUALLY, THERE WAS NO DAMAGE IN THE CONSTRUCTION OF THE DEVICE. A TWIST TIE WAS RETURNED WRAPPED AROUND PO RTIONS OF THE DEVICE. THE ELECTRODE CONTACT WAS FLUSH/ALIGNED WITH THE INSIDE DIAMETER OF THE C-CLIP AS INTENDED. THERE WAS A RED COLORED RESIDUE ON THE CONTACT. ELECTRICALLY, THE RESISTANCE SHALL BE LESS THAN 25 OHMS END TO END AND THE ACTUAL MEASUREMENT WAS 11.8 OHMS WHICH WAS IN SPECIFICATION. FOR FURTHER ANALYSIS, AN X-RAY WAS PERFORMED TO OBSERVE THE INTERNAL CONSTRUCTION OF THE DEVICE AND THERE WAS NO DAMAGE TO THE LEAD WIRE UNDERNEATH THE INSULATION. A REVIEW OF THE GLOBAL COMPLAINT DATA SHOWED ONE SIMILAR COMPLAINT ABOUT THIS LOT NUMBER. IN THE RETURNED CONDITION, THERE WAS NO OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. H6:PREVIOUS CODE B17,C20,D16 ARE NO LONGER VALID. 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 APS ELECTRODE CAN BE USED AT THE BEGINNING WITHOUT ANY PROBLEMS BY TAKING INTO CONSIDERATION THE APPLICATION FOR VAGAL OPERATION AND OBTAINING A BASELINE, HOWEVER, THERE IS AN EVENT IN WHICH THE IT WAS NO LONGER RESPONDING DURING THE OPERATION. THE ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING, HOWEVER, THE DEVICE WAS USED AS IT WAS UNTIL THE END. THE REPORTED PRODUCT WAS CONTINUED TO BE USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

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.