BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZONTAL VERTICAL LUMBAR SYSTEM YE

    MDR report key: 512463 · Received January 16, 2004

    Report

    Report Number
    9612007-2004-00004
    Event Type
    Malfunction
    Date Received
    January 16, 2004
    Report Date
    January 16, 2004
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ANTECHAMBER LEAKED CSF FLUID WHEN IMPLANTED IN THE WHO PATIENT NEEDED A POCKET CREATED FOR THE SHUNT, REQUIRING A BIGGER INCISION TO BE MADE. THE RESERVOIR WAS MANIPULATED MORE THAN USUAL TO ACCOMODATE THE SPACE, AND SUBSEQUENTLY LEAKED WHEN IMPLANTED. THE SURGEON REPLACED THE RESERVOIR WITH ANOTHER ONE BEFORE SURGERY WAS COMPLETE. THE PATIENT IS DOING FINE, AND NO FURTHER LEAKAGE DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZONTAL VERTICAL LUMBAR SYSTEM YE DIFFERENTIAL PRESSURE VALVE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. * 372435

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention