BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081177 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00875
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR DATE UNK. SITE DID NOT FOLLOW CORRECT SCANNING PROTOCOL AND USED NON-AXIAL SLICES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE SAGITTAL IMAGES WERE FLIPPED LEFT/RIGHT ON THE TREON SYSTEM, SURGEON FLIPPED IMAGES CORRECTLY AND PROCEEDED WITH NAVIGATION. THERE WAS NO IMPACT ON PATIENT OUTCOME REPORTED.

    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 5 YR