BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 1942052 · Received November 9, 2010

    Report

    Report Number
    1723170-2010-00079
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 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

    PATIENT ID# AND WEIGHT WERE UNAVAILABLE AT TIME OF THIS REPORT BUT HAS BEEN REQUESTED. SYSTEM INVESTIGATION HAS BEEN REQUESTED AND RESULTS WILL BE REPORTED UPON COMPLETION.

    Description of Event or Problem · 1

    MEDTRONIC REPRESENTATIVE REPORTED THE DOCTOR WAS DOING NAVLOCK IN SURGERY. THE DOCTOR BELIEVED HE WAS INACCURATE WITH THE NAVLOCK. CASE WAS CONTINUED WITHOUT USE OF THE STEALTHSTATION. NO IMPACT ON PATIENT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR