BEUDAMED
    FDA Adverse Event Other Summary report: N

    H/V LUMBAR VALVE SYSTEM YELLOW, (85-125, 265-365)

    MDR report key: 1202790 · Received October 16, 2008

    Report

    Report Number
    9612007-2008-00031
    Event Type
    Other
    Date Received
    October 16, 2008
    Date of Event
    September 22, 2008
    Report Date
    October 15, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE ATTACHED JOURNAL ARTICLE WAS PRESENTED AT INTEGRA'S POST MARKETING SURVEILLANCE MEETING AT INTEGRA NEUROSCIENCES IMPLANTS FACILITY IN (B) (6). THE ARTICLE ENTITLED "MANAGEMENT OF LUMBAR SHUNT SITE SWELLING IN CHILDREN." REFLECTS A STUDY OF SHUNT PATIENTS AT (B) (6) HOSPITAL OF (B) (6). THE FOCUS OF THIS STUDY WAS TO REVIEW AND DEFINE THE ORIGIN AND MANAGEMENT OF LUMBAR SHUNT SITE SWELLING AND CEREBROSPINAL (CSF) LEAKAGE AS SEEN IN CHILDREN WHO HAD UNDERGONE PLACEMENT OF A PERCUTANEOUS LUMBAR SHUNT DUE TO RECURRENT PROBLEMS WITH A VENTRICULAR SHUNT. ALL SHUNTS UTILIZED IN THE STUDY HAD AN INTEGRA HORIZONTAL VERTICAL VALVE INCLUDED IN THE SYSTEM. ALL SHUNT PLACEMENT SURGERIES HAD BEEN PERFORMED USING THE STANDARD PERCUTANEOUS TECHNIQUE WITH THE AID OF A 14-GAUGE TUOHY NEEDLE. THE STUDY CONCLUDED THAT THE LUMBAR SHUNT SWELLING IS PREDOMINANTLY A CONSEQUENCE OF PERICATHETER CSF LEAKAGE FROM THE MISMATCH IN THE DURAL OPENING WHICH CORRESPONDS TO THE OUTER DIAMETER OF THE 14 GAUGE TUOHY NEEDLE AND THE SMALLER PROXIMAL LUMBAR CATHETER. CSF LEAKAGE IS A KNOWN ADVERSE REACTION WITH THE USE OF OUR HORIZONTAL VENTRICULAR LUMBAR VALVE SYSTEM AS STATED IN THE PRODUCT'S INSTRUCTIONS FOR USE. THE STUDY SEEMS TO RECOMMEND MODIFICATION IN THE CATHETER INSERTION PROCEDURE TO EFFECTIVELY MANAGE CSF LEAKAGE, IT IS INTEGRA'S OPINION THAT THE STUDY DOES NOT IMPLY OR ALLEGE ANY DEVICE MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H/V LUMBAR VALVE SYSTEM YELLOW, (85-125, 265-365) HORIZONTAL-VERTICAL LUMBAR VALVE SYSTEMS JXG INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other