BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX ELEMENT

    MDR report key: 1963680 · Received December 21, 2010

    Report

    Report Number
    1723170-2010-00211
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME OF THIS REPORT. DEVICE MANUFACTURER DATE NOT AVAILABLE AT TIME OF THIS REPORT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE MONITOR FLICKERED BLACK FOR A SPLIT SECOND AND THEN DISPLAYED PROPERLY. THE SURGEON WAS NOT NAVIGATING AND DID NOT NOTICE THIS OCCURRENCE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARX ELEMENT STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. ELEMENT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK