BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV CD HORIZON SOLERA 4.75MM DRIVER

    MDR report key: 2181091 · Received July 7, 2011

    Report

    Report Number
    1723170-2011-01193
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT AVAILABLE FROM THE SITE AT THE TIME OF THIS REPORT. SERIAL NUMBER/LOT NUMBER NOT AVAILABLE AT THIS TIME. DEVICE MANUFACTURE DATE IS DEPENDENT ON THE SERIAL NUMBER/LOT NUMBER PROVIDED. NOT AVAILABLE AT THIS TIME. RMA ISSUED. PART HAS NOT BEEN RETURNED FOR EVALUATION AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE SOLERA SCREWDRIVER FOR THE STEALTHSTATION TREON SYSTEM WAS DAMAGED. NO FURTHER DETAILS WERE PROVIDED, ALTHOUGH THE SITE REQUESTED REPLACEMENT FOR THE PART. NO HARM TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAV CD HORIZON SOLERA 4.75MM DRIVER STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. TREON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1