BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3168435 · Received June 13, 2013

    Report

    Report Number
    1723170-2013-00437
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. IT WAS NOTED THAT THE RETRACTABLE POWER CABLE APPEARED TO HAVE BEEN CUT ON THE METAL EDGE OF THE CORD RETRACTOR, AND MAY HAVE CAUSED DAMAGE TO THE ISOLATION TRANSFORMER. SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED TO MANUFACTURER FOR EVALUATION. UNABLE CONFIRM COMPLAINT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    REPLACING THE POWER CABLE RESOLVED THE ISSUE. SYSTEM IS NOW FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A DAMAGED RETRACTABLE POWER CABLE ON A NAVIGATION SYSTEM. THERE WAS NO PATIENT PRESENT WHEN THIS WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270118 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1