BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3250869 · Received July 29, 2013

    Report

    Report Number
    1723170-2013-00553
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED TO MANUFACTURER FOR EVALUATION/INSPECTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT ON A PERIODIC CHECK OF THE DEVICE, THE SITE INTERNAL TECHNICAL DEPARTMENT NOTED THEIR DOUBLE STAR ADAPTER DID NOT FIX CORRECTLY. THERE WAS NO PATIENT PRESENT WHEN THIS CONCERN WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353864 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1