BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2150597 · Received June 22, 2011

    Report

    Report Number
    1723170-2011-01137
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMAS ISSUED FOR CAMERA CABLE, SPRING ARM ASSEMBLY, COMM CABLE AND COMPUTER/PCI CARD. INVESTIGATION FINDS THAT CHANGING THE OPTICAL PORTS ON THE COMPUTER AND THE POWER COMMUNICATION CABLE RESOLVED THE ISSUE WITH THE SYSTEM. THE SYSTEM IS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE CAMERA CABLE ON THE STEALTHSTATION TREON GUIDANCE SYSTEM IS BAD. THE MEDTRONIC REP INITIALLY NOTICED THE CAMERA CYCLING. AFTER SWAPPING OUT CAMERAS AND THE CABLE AND THEN TESTING BOTH ON ANOTHER SYSTEM, FOUND THAT BOTH CAMERAS ARE WORKING FINE. THERE WAS NO PATIENT 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