BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF-FLOW CONTROL VALVE, ULTRA SMALL, MEDIUM PRESSURE

    MDR report key: 2142205 · Received May 26, 2011

    Report

    Report Number
    2021898-2011-00112
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 2, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K873247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT AND PASSED REFLUX AND LEAK TESTING. THE DEVICE MET SPECIFICATIONS FOR PREIMPLANTATION TESTING AND PRESSURE-FLOW TESTING, EXCEPT FOR AT 46.8 ML/HR @ 0 CM H2O. PROTEINACEOUS DEBRIS WAS FOUND ON THE INTERIOR OF THE VALVE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT CSF DID NOT FLOW NORMALLY THROUGH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-FLOW CONTROL VALVE, ULTRA SMALL, MEDIUM PRESSURE JXG MEDTRONIC NEUROSURGERY C45865

    Patients

    Seq Age Sex Outcome Treatment
    1