SITUATE

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

ACCORDING TO THE REPORTER, DURING PROCEDURE, AS SURGERY WAS BEING WRAPPED-UP THE SCANNING DEVICES WAS KEPT GETTING FLIP-FLOPPED RESULTS OF CLEAR VS DETECTION, AS SOMETHING BETWEEN THE MAT AND WAND WAS COMING UP UNCLEAR. MAT WAS SAYING "DETECTION" AND WAND WAS NOT DETECTING ANYTHING. THEY NEEDED TO ORDER AN X-RAY TO DETERMINE FINAL DIAGNOSTICS. X-RAY WAS NEGATIVE. THERE WAS UNNECESSARY RADIATION DUE TO PROLONGED USE OF PRODUCT. THE MAT WAS PLUGGED IN WITH THE REPRESENTATIVE ON SIDE THE MAT FAILED IMMEDIATELY UPON THE CONSOLE TURNING ON.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCTS: 01-0043, CONSOLE; MODEL 200X, (SN: (B)(6)) 01-0046, 01-0046 BLAIR PORT WAND X, (SN: (B)(6)). 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING PROCEDURE, AS SURGERY WAS BEING WRAPPED-UP, THE SCANNING DEVICES WAS KEPT GETTING FLIP-FLOPPED RESULTS OF CLEAR VS DETECTION AS SOMETHING BETWEEN THE MAT AND WAND WAS COMING UP UNCLEAR. MAT WAS SAYING "DETECTION" AND WAND WAS NOT DETECTING ANYTHING. THEY NEEDED TO ORDER AN X-RAY TO DETERMINE FINAL DIAGNOSTICS. X-RAY WAS NEGATIVE. THERE WAS UNNECESSARY RADIATION DUE TO PROLONGED USE OF PRODUCT.