BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA BURR HOLE 16MM, LEV 1.5

    MDR report key: 1200070 · Received October 15, 2008

    Report

    Report Number
    2021898-2008-00237
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K934545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURE.

    Description of Event or Problem · 1

    THE VALVE WAS LEAKING FROM A TEAR IN THE RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA BURR HOLE 16MM, LEV 1.5 84JXG JXG MEDTRONIC NEUROSURGERY NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1