BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF-FLOW CONTROL VALVE, BURR HOLE, 16MM, MEDIUM PR

    MDR report key: 1191230 · Received September 26, 2008

    Report

    Report Number
    2021898-2008-00223
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K831678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED WAS FOR A BROKEN VALVE. THERE WERE NO INDICATIONS OF BREAKAGE DURING LAB EVAL. THE VALVE WAS PATENT AND PASSED LEAK TESTING. THE VALVE PERFORMANCE MET SPECIFICATIONS FOR PRESSURE-FLOW TESTING AT 46.8 ML/HR @ 0 CM H2O AND PREINPLANTATION TESTING. THE VALVE, HOWEVER, DID NOT PASS REFLUX TESTING AND DID NOT MEET ESTABLISHED PRESSURE-FLOW AT 5.5 ML/HR @ 0 CM H2O DUE TO CRYSTALINE DEBRIS FOUND UNDERNEATH THE VALVE MEMBRANE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR PRODUCT ARE 100% TESTED AT THE TIME OF MFG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-FLOW CONTROL VALVE, BURR HOLE, 16MM, MEDIUM PR 84JXG JXG MEDTRONIC NEUROSURGERY NA A55301

    Patients

    Seq Age Sex Outcome Treatment
    1