MON-A-THERM

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 AFTER CONNECTING THE CABLE, A  5°C WAS DISPLAYED, WHICH WAS AN IMPOSSIBLE VALUE, SO THE SENSOR WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

ADDITIONAL INFO: D9 (RETURN DATE), G3, H2, H3, H6. H3. EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. AN ELECTRICAL TEST WAS PERFORMED, THE SAMPLE WAS TESTED FOR RESISTANCE, AND THE READING IS OUT SPECIFICATION. IT WAS REPORTED THAT AFTER CONNECTING THE CABLE, A 5°C WAS DISPLAYED, WHICH WAS AN IMPOSSIBLE VALUE. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. INSTRUCTIONS FOR USE (IFU) WARNINGS: DO NOT USE IF PACKAGE IS OPENED OR DAMAGED. USE ONLY WITH COMPATIBLE INTERCONNECT CABLES AND MONITORS. NOT DOING SO MAY RESULT IN AN INACCURATE MEASURED TEMPERATURE. DO NOT MODIFY THIS DEVICE. MODIFICATIONS COULD RESULT IN INACCURATE TEMPERATURE MEASUREMENT. DO NOT ATTEMPT TO FORCE CONNECTION OF THE SENSOR. THE CONNECTORS ARE KEYED BY SHAPE. FORCING THE CONNECTION COULD RESULT IN DAMAGE TO THE SENSOR OR CABLE CONNECTOR AND A RESULTING INABILITY TO FUNCTION. ENSURE THAT THE CABLE CONNECTOR DOES NOT LIE IN AN AREA WHERE SOLUTIONS MAY POOL DURING THE SURGICAL PROCEDURE. 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.