BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA VALVE, SMALL, PERFORMANCE LEVEL 1.5

    MDR report key: 1032224 · Received April 21, 2008

    Report

    Report Number
    2021898-2008-00093
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 25, 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 RETURNED VALVE WAS PATENT AND PASSED SIPHON AND REFLUX TESTING. IT WAS WITHIN SPECIFICATIONS FOR PRESSURE-FLOW TESTS PERFORMED AT -50CM HYDROSTATIC PRESSURE. THE VALVE FELL BELOW SPECIFICATIONS FOR PRESSURE-FLOW TESTING PERFORMED AT 0CM HYDROSTATIC PRESSURE. DEBRIS WITHIN THE VALVE MAY INTERFERE WITH THE MEMBRANE RESULTING IN LOW PRESSURE-FLOW CHARACTERISTICS. THE VALVE DID NOT PASS THE LEAK TEST DUE TO A SMALL TEAR IN THE DELTA CHAMBER. A REVIEW OF THE MANUFACTURING RECORD'S WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF OUR PRODUCTS ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE WAS NOT WORKING PROPERLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1