BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDM LUMBAR DRAINAGE KIT WITH 120ML GRADUATED CHAMBER

    MDR report key: 2162070 · Received July 6, 2011

    Report

    Report Number
    2162070
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANESTHESIOLOGIST WAS PREPPING PATIENT FOR AORTIC ROOT REPLACEMENT AND WAS PLACING AN EXTERNAL LUMBAR DRAIN AND MONITOR DRAIN. WHILE MANEUVERING THE LOWER PORTION OF THE CATHETER, IT WAS SAID TO HAVE "SHREDDED" IN THE LUMBAR SPACE, SEPARATING FROM THE MAIN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDM LUMBAR DRAINAGE KIT WITH 120ML GRADUATED CHAMBER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY * 1135 1890

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR