BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR PROBE

    MDR report key: 2060822 · Received March 11, 2011

    Report

    Report Number
    1723170-2011-00634
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K954276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE MANUFACTURE DATE NOT AVAILABLE AT TIME OF THIS REPORT. RMA ISSUED. INVESTIGATION SHOWED THAT THE TIP OF THE PROBE HAD BEEN TWISTED. WHILE THERE WAS NO PATIENT PRESENT, THIS ISSUE IS BEING REPORTED BECAUSE, A BENT PROBE THAT IS NOT NOTICED COULD RESULT IN INACCURATE NAVIGATION BECAUSE, THE SOFTWARE IS NOT EXPECTING THAT GEOMETRY FROM THE INSTRUMENT.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED, A BENT LUMBAR PROBE. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR PROBE STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 100707

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE