BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

    MDR report key: 2177969 · Received July 6, 2011

    Report

    Report Number
    2021898-2011-00139
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 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. HOWEVER, THE VALVE DID NOT MEET REQUIREMENTS FOR PRESSURE-FLOW TESTING OR PRE-IMPLANTATION PRESSURE. NO IMPACT TO THE PT WAS REPORTED. A REVIEW OF THE MANUFACTURING 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 THE VALVE WOULD NOT WORK PROPERLY DURING THE PRE-IMPLANTATION TEST. IT WAS ALLEGED THAT FLOW WAS OCCURRING IN BOTH DIRECTIONS FROM THE SAME CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY C69498

    Patients

    Seq Age Sex Outcome Treatment
    1