BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA 2 SHUNT ASSEMBLY, SMALL

    MDR report key: 1001643 · Received February 18, 2008

    Report

    Report Number
    2021898-2008-00041
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS PATENT AND PASSED SIPHON AND REFLUX TESTING. IT WAS WITHIN SPECIFICATIONS FOR ALL PRESSURE-FLOW AND PREIMPLANTATION TESTS. THE VALVE DID NOT PASS THE LEAK TEST DUE TO A SMALL TEAR IN THE TOP OF THE DELTA CHAMBER. 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 HOSP STAFF DETECTED A LEAK IN THE VALVE DURING PREIMPLANTATION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2 SHUNT ASSEMBLY, SMALL 84JXG JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1