BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA NEUROSCIENCES HERMETIC LUMBAR CATHETER CLOSED

    MDR report key: 1001430 · Received February 19, 2008

    Report

    Report Number
    MW5005600
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 19, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTEGRA LUMBAR DRAIN CATHETER FRACTURED DURING LUMBAR CEREBRAL SPINAL FLUID DRAINAGE CATHETER PLACEMENT UNDER FLUOROSCOPIC GUIDANCE. DISTAL ONE HALF OF CATHETER REMAINED IN PT'S SPINAL CANAL/PROXIMAL END IN SURROUNDING TISSUE. SURGICAL PROCEDURE WAS ULTIMATELY PERFORMED TO REMOVE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA NEUROSCIENCES HERMETIC LUMBAR CATHETER CLOSED NONE JXG INTEGRA NEUROSCIENCES INS 5010 1073227

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability