BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA VALVE REG, LEVEL 1.5

    MDR report key: 1011388 · Received March 11, 2008

    Report

    Report Number
    2021898-2008-00060
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 15, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT AND PASSED SIPHON AND REFLUX TESTING. THE VALVE PASSED PRESSURE/FLOW TESTING AT 20.4 ML/HR AT 50CM BUT DID NOT PASS ALL OTHER PRESSURE/FLOW AND PREIMPLANTATION TESTING. THE VALVE FAILED LEAK TESTING DUE TO A TEAR IN THE TOP OF THE DELTA CHAMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NOT LOT NUMBER WAS PROVIDED. ALL OF OUR PRODUCTS ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE WAS MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA VALVE REG, LEVEL 1.5 84JXG JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1