APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS FOUND THAT THE DEVICE AND THE PACKAGING TRAYS WERE PLACED IN A (DOUBLE) PLASTIC BAG AND RETURNED IN A LARGE WHITE ENVELOPE. THE DEVICE WAS FREE OF CONTAMINATION WHEN RETURNED. DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE LEAD WIRE CONTACT WAS NOT EXPOSED/FLUSH TO THE C-CLIP BODY OPENING. THE LEAD WIRE CONTACT WAS RECESSED INSIDE THE C-CLIP BODY BY APPROXIMATELY 0.04 INCHES FROM THE C-CLIP OPENING. THE RESISTANCE SHALL BE LESS THAN 25 OHMS END TO END, AND THE ACTUAL MEASUREMENT WAS 11.5 OHMS WHICH WAS IN SPECIFICATION. THE COMPLAINT WAS CONFIRMED, DUE TO AN OUT OF SPECIFICATION CONDITION. 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 THYROIDECTOMY PROCEDURE, APS ELECTRODE WAS NOT IN CORRECT LOCATION. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

H6: ANNEX D/FDC CODES 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.