MON-A-THERM

Additional Manufacturer Narrative

D10: CONCOMITANT PRODUCT: 90044, 90044 400 GENERAL PURPOSE SENSOR 12X50 (LOT#20L0429JZX). 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 TEMPERATURE PROBE WAS IN PLACE FOR 48 HOURS. AFTER REMOVAL FOR INTIMATE WASHING, REINSTALLATION OF THE DEVICE. MALFUNCTION WITH TEMPERATURE DIFFERENCE OF UP TO 2 DEGREES LESS THAN THE SOCKET TYMPANIC. CHANGING THE PROBE, USING THE SAME REFERENCE, THE SAME BATCH AND IT HAD SIMILAR PROBLEM. THERE WAS NO PATIENT HARM.