BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 510237 · Received January 13, 2004

    Report

    Report Number
    9612007-2004-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2004
    Report Date
    January 12, 2004
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT HAD THE VALVE IMPLANTED FOR TWO WEEKS. CEREBRAL SPINAL FLUID COLLECTION POOLED IN THE DISTAL REGION, CAUSING AN INFECTION AND THE NEED FOR SURGERY. THE TREATING NEUROSURGEON REPORTED THE TUBING ON THE INLET SIDE OF THE VALVE FRACTURED CAUSING CSF COLLECTION AND INFECTION REQUIRING SURGICAL REMOVAL. THE SALES REP REPORTED THE BREAK OCCURRED WHERE THE RESERVOIR CONNECTS TO THE CONNECTOR, THE CONNECTION WAS STILL TIED TOGETHER BUT IT WAS AT THAT AREA WHERE IT LOOKED LIKE THE TUBING HAD "DISCONNECTED". THE NEUROSURGEON REPORTED THIS APPEARED TO BE A "CLEAN" BREAK RATHER THAN A FRACTURE OR NICK, WHICH ONE WOULD EXPECT TO BE MORE RAGGED. THE NEUROSURGEON INDICATED THIS IS THE FIRST TIME THIS HAS HAPPENED WITH THIS DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention