BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUET

    MDR report key: 3811972 · Received March 14, 2014

    Report

    Report Number
    3811972
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH A THORACIC DESCENDING ANEURYSM HAD A LUMBAR DRAIN PLACED BY INTERVENTIONAL RADIOLOGY. OVERNIGHT ON THE NURSING UNIT STAFF NOTED THAT THE DRAIN WAS LEAKING AND PATIENT WAS COMPLAINING OF A HEADACHE. MD WAS CALLED AND ANESTHESIA CAME TO REMOVE THE DRAIN. WHILE REMOVING THE DRAIN THE CAP CAME OFF COMPLETELY FROM THE REST OF THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153716 DUET SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY EDM 206761471

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR