BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF-BURR HOLE VALVE 16 MM, MEDIUM PRESSURE

    MDR report key: 3070578 · Received April 17, 2013

    Report

    Report Number
    2021898-2013-00143
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    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 VALVE WAS PATENT. PROTEINACEOUS DEBRIS WAS OBSERVED IN THE INTERIOR OF THE VALVE. IT MET THE REQUIREMENTS FOR REFLUX, LEAKAGE AND PREIMPLANTATION TESTS. IT ALSO MET ALL OF THE REQUIREMENTS FOR PRESSURE-FLOW TESTS. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER THE SURGEON IMPLANTED THE VALVE NO CSF WAS OBSERVED COMING OUT OF THE DISTAL CATHETER. IT WAS ALSO REPORTED THAT THERE WERE NO PT INJURIES OR SYMPTOMS RELATED TO THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164659 CSF-BURR HOLE VALVE 16 MM, MEDIUM PRESSURE JXG - SHUNT, CENTRAL, NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D30168

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR