BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2172122 · Received June 24, 2011

    Report

    Report Number
    1723170-2011-01153
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 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. RMA ISSUED FOR TREON POWER COMM CABLE. MEDTRONIC INVESTIGATION FINDS THE FISCHER CONNECTOR SHELL IS DAMAGED IN AN OUT OF ROUND CONDITION. NOT ABLE TO CONNECT TO THE MATING CONNECTOR. A CONTINUITY CHECK REVEALED AN OPEN FROM PIN 5 OF THE FISCHER CONNECTOR TO PIN 2 OF THE DB9 CONNECTOR.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE CAMERA IS CYCLING ON THE STEALTHSTATION TREON SYSTEM. SHE EXPLAINED THAT SHE WAS ABLE TO SWAP THE POWER COMM. CABLE WITH THE CABLE FROM ANOTHER SYSTEM AT THE SITE AND THAT RESOLVED THE ISSUE. THE CABLE DOES NOT DISPLAY ANY SIGNS OF DAMAGE OR WEAR. 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