BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II SNAP SHUNT, REGULAR, BIOGLIDE

    MDR report key: 1030526 · Received April 17, 2008

    Report

    Report Number
    2021898-2008-00092
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 18, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT AND PASSED REFLUX TESTING. IT WAS WITHIN SPECIFICATIONS FOR ALL PRESSURE-FLOW AND PREIMPLANTATION TESTS CONDUCTED AT 0CM HYDROSTATIC PRESSURE. THE VALVE DID NOT PASS THE SIPHON TEST, OR PRESSURE-FLOW TESTS CONDUCTED AT -50CM HYDROSTATIC PRESSURE. DEBRIS IN THE VALVE MAY INTERFERE WITH THE DELTA CHAMBER MEMBRANE RESULTING IN SIPHONING. THE VALVE DID NOT PASS THE LEAK TEST DUE TO HOLES IN THE RESERVOIR AND ADJUSTMENTS MECHANISM. A REVIEW OF THE MFG RECORDS 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 BECAME OCCLUDED SEVERAL MOS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II SNAP SHUNT, REGULAR, BIOGLIDE 84JXG JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1