BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081263 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00807
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    December 15, 2009
    Report Date
    December 15, 2009
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO AS NO PT WAS INVOLVED IN THIS CONCERN. TRACKING WAS REDUCED TO LESS THAN 5 FEET AFTER WARM UP ON BOTH CAMERAS, SERIAL #S ARE (B)(4). THE 2 POSITION SENSOR UNIT (PSU) FAILED THE AAK TESTS, ALONG WITH HIGH LINE SEPARATION. THE 2 POSITION SENSOR UNIT (PSU) ARE OUT OF CALIBRATION.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED 2 DIFFERENT POSITION SENSOR UNIT ON THE TREON SYSTEM WERE NOT TRACKING INSTRUMENTS. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1