BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H/V LUMBAR VALVE SYSTEM WHITE, (50-80, 230-320)

    MDR report key: 888513 · Received August 2, 2007

    Report

    Report Number
    9612007-2007-00037
    Event Type
    Injury
    Date Received
    August 2, 2007
    Report Date
    August 2, 2007
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE COMPLAINT WAS SUBMITTED PREVIOUSLY BY THE UNIVERSITY RELATING TO THE INCIDENT DESCRIBED WITHIN THE PUBLICATION. NO PRODUCT WAS RETURNED FOR EVALUATION, AND NO LOT NUMBER WAS PROVIDED. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. EACH VALVE IS TESTED FOR OPERATING PRESSURE AT THE END OF THE MFG PROCESS, AND A LEAK TEST IS PERFORMED. A REVIEW OF THE COMPLAINTS TRACKING DATABASE WAS CONDUCTED. EIGHTEEN SIMILAR COMPLAINTS FOR PRODUCT IN THE SAME FAMILY HAD BEEN REPORTED SINCE 2002. DURING THE SAME TIME PERIOD, 5084 UNITS HAD BEEN RELEASED FOR DISTRIBUTION. INTRACRANIAL HYPOTENSION AND CSF LEAKAGE ALONG THE SHUNT PATHWAY ARE COMPLICATIONS OF VALVE THERAPY ALREADY STATED IN THE PRODUCT'S INSTRUCTIONS FOR USE. NO FURTHER INVESTIGATION NOR CORRECTIVE ACTION IS DEEMED REQUIRED.

    Description of Event or Problem · 1

    A PUBLICATION WAS TRANSMITTED BY INTEGRA NEUROSCIENCES IN THE COURSE OF A POST MARKET SURVEILLANCE MEETING: "INTRACRANIAL HYPOTENSION CAUSED BY LEAKAGE OF CEREBROSPINAL FLUID FROM THE THE CAL SAC AFTER LUMBOPERITONEAL SHUNT PLACEMENT" (Y.J. LIAO, ET AL, J NEUROSURG, 107:173-177, 2007). THE ARTICLE SITES A COMPLICATION OF LUMBOPERITONEAL SHUNT PLACEMENT, INTRACRANIAL HYPOTENSION FROM LEAKAGE OF CEREBROSPINAL FLUID THROUGH A DEFECT OF THE LUMBAR DURA CREATED BY A SHUNT CATHETER. THE SHUNT, AN H-V LUMBAR VALVE, WAS EXPLANTED 9 DAYS AFTER IMPLANTATION IN A 47 YEARS OLD PT. THE PT WAS TREATED SUCCESSFULLY WITH A BLOOD PATCH AT THE LEAK SITE. "IT WAS UNCLEAR WHETHER THE LEAK AROSE FROM THE ACTUAL CATHETER INSERTION SITE, LOCATED DORSALLY, OR WHETHER A SEPARATE HOLE WAS PRESENT IN THE VENTRAL DURA MATER. SUCH A HOLE MIGHT HAVE BEEN CAUSED BY INADVERTENT PUNCTURE OF THE DURA DURING SHUNT INSERTION OR BY EROSION OF THE CATHETER THROUGH THE DURA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H/V LUMBAR VALVE SYSTEM WHITE, (50-80, 230-320) DP VALVE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention