BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON SYSTEM

    MDR report key: 1915459 · Received November 4, 2010

    Report

    Report Number
    1723170-2010-00074
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS INVOLVED IN THIS CASE. THIS WAS A PREVENTATIVE MAINTENANCE VISIT. MANUFACTURE DATE HAS BEEN REQUESTED. PSU RETURNED FOR EVAL. PASSIVE TRACKING WAS OBSERVED TO BE LESS THAN 6 FEET AFTER WARM UP. THE PSU PASSED THE AAK TEST AT .24MM BUT WITH HIGH LINE SEPARATION. PSU WAS REPLACED AND NOW THE CAMERA IS TRACKING NORMALLY. ROOT CAUSE WAS ELECTRICAL.

    Description of Event or Problem · 1

    DURING A PREVENTATIVE MAINTENANCE VISIT, THE MEDTRONIC REP SUSPECTED THE POLARIS CAMERA WAS GOING OUT OF CALIBRATION. IT WAS TRACKING FINE AT CLOSE DISTANCE BUT STARTED FLICKERING AFTER 4FT. DISCOVERED PSU OUT OF CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON SYSTEM STEREOTAXIC SURGICAL SYSTEM (HAW) HAW MEDTRONIC NAVIGATION TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE