APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS FOUND THAT THE DEVICE AND THE PACKAGING CARTON WERE RETURNED IN A LARGE RESEALABLE BAG. THERE WAS NO SIGNIFICANT DAMAGE TO THE PACKAGING CARTON. WHEN RETURNED, THE LEAD WIRE CONTACT WAS NOT EXPOSED/FLUSH TO THE C-CLIP BODY OPENING, IT WAS RECESSED (UPON RETURN) INSIDE THE C-CLIP BODY BY APPROXIMATELY 0.06 INCHES FROM THE C-CLIP OPENING. THE RESISTANCE SHALL BE LESS THAN 25 OHMS END TO END, AND THE ACTUAL MEASUREMENT WAS 11.7 OHMS WHICH WAS IN SPECIFICATION. H6: PREVIOUSLY APPLIED CODES FDM B17, FDR C20 AND FDC D16 ARE NO LONGER APPLICABLE.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.

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.

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 INTRA-OP DURING ESOPHAGECTOMY PROCEDURE, THERE WAS NO RESPONSE OBTAINED EVEN AFTER CONNECTING TO THE PATIENT. THE WAVEFORMS COULD BE OBTAINED WITHOUT ANY PROBLEMS WHEN THEY WERE CONNECTED BY OPENING A NEW PRODUCT. THE ELECTRODE WAS USED AFTER OPENING FROM A SEALED PACKAGE AND THERE WAS NO DAMAGE NOTICED IN IT. THE PROCEDURE WAS EXTENDED BY 10 MINS. THERE WAS NO PATIENT IMPACT.