APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS OF THE DEVICE FOUND THAT ONLY ELECTRODE WAS RETURNED, NO OTHER COMPONENTS INCLUDED WITH THE ELECTRODE. THE ELECTRODE WAS PLACED IN A DOUBLE PLASTIC BAG AND RETURNED IN A LARGE WHITE ENVELOPE. THERE WERE NO TRACES OF CONTAMINATION OBSERVED ON THE RETURNED ELECTRODE. HOWEVER, IT WAS OBSERVED THAT THE LEAD WIRE CONTACT WAS COMPLETELY EXPOSED, THE C-CLIP BODY WAS MISSING AND NOT RETURNED WITH THE ELECTRODE. FOR FURTHER ANALYSIS, THE RESISTANCE SHALL BE LESS THAN 25 OHMS END TO END, AND THE ACTUAL MEASUREMENT WAS 14.5 OHMS WHICH WAS IN SPECIFICATION. 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 INTRA-OP DURING TOTAL THYROIDECTOMY WITH LEFT NECK DISSECTION, THE APS ELECTRODE WAS NOT FUNCTIONING WHEN ATTEMPTED TO PLACE ON THE VAGUS NERVE. UPON FURTHER INSPECTION, IT WAS DISCOVERED THAT THE METAL PART OF THE APS ELECTRODE HAD SLIPPED OUT OF THE SILICONE CLIP. THE INCIDENT MAY HAVE BEEN DUE TO A PRODUCT DEFECT, AS THERE WAS NO EXCESSIVE FORCE OR PULLING ACTION APPLIED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCT. THERE WAS NO PATIENT IMPACT.