APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Additional Manufacturer Narrative

H3: THE ANALYSIS OF THE DEVICE CONCLUDED THAT THE C-CLIP CONTACT WAS NOT EXPOSED/FLUSH WITH THE INSIDE DIAMETER OF THE CLIP BODY UPON RETURN. THE CONTACT WAS RECESSED INSIDE THE CLIP BODY BY 0.06 INCHES (FROM THE CLIP OPENING TO THE DISTAL TIP OF THE CONTACT). DISTAL PORTIONS OF THE WIRE WERE DEFORMED (SPIRALED/NOT STRAIGHT) NEAR THE C-CLIP. THE RESISTANCE SHALL BE LESS THAN 25 OHMS END TO END, AND THE ACTUAL MEASUREMENT WAS 11.6 OHMS WHICH WAS IN SPECIFICATION. THE COMPLAINT WAS CONFIRMED, DUE TO AN OUT OF SPECIFICATION CONDITION. H6: PREVIOUSLY APPLIED CODES FDM B21, FDR C21, FDC D16 AND IMG G0201501 ARE NO LONGER APPLICABLE.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.

Description of Event or Problem

IT WAS REPORTED THAT DURING NECK TUMOR REMOVAL SURGERY, AFTER ATTACHING THE APS ELECTRODE TO THE VAGUS NERVE WHILE ATTEMPTING TO TAKE A BASELINE THE LEAD-OFF DISPLAY APPEARED, AND STIMULATION WAS NOT POSSIBLE. WHEN CHECKING THE APS ELECTRODE, FOUND THAT THE ELECTRODE PART WAS NOT EXPOSED AND HAD COME OUT. A SPARE NEW PRODUCT WAS OPENED AND USED WITHOUT ANY PROBLEMS. 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.