BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081195 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00806
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    November 16, 2009
    Report Date
    November 16, 2009
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE IS UNK. PASSIVE TRACKING WAS FOUND TO BE NORMAL THROUGHOUT THE VOLUME DURING FUNCTIONAL TESTING. HOWEVER, THE PSU FAILED THE AAK TEST AT .59MM WITH ABOVE NORMAL LINE SEPARATION OF 1.75MM. THE PSU IS OUT OF CALIBRATION.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED, THE SITE'S TREON CAMERA COULD NOT TRACK ANY PASSIVE 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