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, THE CONSOLE HAD A SYSTEM ERROR. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT MULTIPLE SCANS WERE ATTEMPTED WITH THE TEST BLAIR-PORT WAND, THE DEVICE ALERTED FOR METAL PRESENCE EACH SCAN/FALSE DETECTION. REPLACED ANALOGUE BOARD IN THE CONSOLE AND ALL SCAN WITH THE BLAIR PORT WAND WERE CLEAR.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6 H3. EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED NORMAL WEAR. THE DEVICE WAS CONNECTED TO POWER AND POWERED ON, PASSING POST. A TEST BLAIR-PORT WAND AND RF DETECTION MAT WERE CONNECTED, AND THE DEVICE RECOGNIZED BOTH ACCESSORIES PROPERLY. MULTIPLE SCANS WERE COMPLETED WITH THE MAT, THE DEVICE FUNCTIONED PROPERLY ALARMING FOR DETECTION ONLY WHEN A TEST RF CHIP WAS BROUGHT WITHIN RANGE. MULTIPLE SCANS WERE ATTEMPTED WITH THE BLAIR-PORT WAND, THE DEVICE ALERTED FOR METAL PRESENCE EACH SCAN. ROOT CAUSE WAS ISOLATED TO THE TOP ANALOG BOARD. AFTER REPLACING THE COMPONENT, THE DEVICE COMPLETED MULTIPLE WAND SCANS WITH NO FAULTS. IT WAS REPORTED THAT THE CONSOLE HAD A SYSTEM ERROR. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO A COMPONENT FAILURE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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.