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 A NEW UNIT OF APS ELECTRODE WAS OPENED. ONCE THE SURGEON ATTACHED THE APS TO THE VAGUS NERVE OF THE PATIENT AND THERE WAS NO BASELINE READING AS THE MACHINE COULDN¿T DETECT THE ELECTRODE. CHECKED THE APS AND THERE WAS NO VISIBLE ELECTRODE IN APS CLIP. APS ELECTRODE WAS REPLACED AND PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

E1, E2 AND E3: UPDATED. H3: ANALYSIS FOUND 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). ELECTRICALLY, FOR FURTHER ANALYSIS, THE RESISTANCE SHALL BE LESS THAN 25 OHMS END TO END, AND THE ACTUAL MEASUREMENT WAS 11.6 OHMS WHICH WAS IN SPECIFICATION. IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. H6: PREVIOUSLY SUBMITTED CODES FDM B17, FDR C20 AND FDC D16 ARE NO LONGER APPLICABLE. ADDITIONAL CODE IMG G0202502 IS NO LONGER APPLICABLE.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.