SITUATE

Additional Manufacturer Narrative

EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE CONSOLE WAS RECEIVED WITH THE LOWER RIGHT CORNER TAB BROKEN. THE VERISPHERE WAS CONNECTED TO THE UUT WITH THE RF SENSOR PLACED IN RANGE AND THE SENSOR WAS DETECTED. THE SENSOR WAS REMOVED FROM THE AREA AND THE SENSOR WAS NOT DETECTED. THE UNIT ALSO HAD A HOUSING FAILURE. IT WAS REPORTED THAT THE DEVICE GAVE A FALSE POSITIVE DETECTION. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. IT WAS ALSO REPORTED THAT THE DEVICE WAS PHYSICALLY DAMAGED. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A CRACKED CASING AND WOULD DETECTS SPONGES WHEN THERE WAS NONE. THERE WAS NO PATIENT INVOLVEMENT.