BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1961678 · Received December 28, 2010

    Report

    Report Number
    1723170-2010-00231
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    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 PRESENT. THE SYSTEM WAS EVALUATED AT THE SITE. THE DEVICE MALFUNCTION WAS REPLICATED DURING TESTS BY A MEDTRONIC REP. A RMA WAS OPENED FOR THE REPLACEMENT OF THE CAMERA.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE SYSTEM WOULD NOT TRACK PASSIVE INSTRUMENTS AND FRAMES THAT HAVE MORE THAN FOUR TRACKING SPHERES ATTACHED. THERE WAS NO PT 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 NONE