BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 2840535 · Received October 9, 2012

    Report

    Report Number
    2840535
    Event Type
    Injury
    Date Received
    October 9, 2012
    Date of Event
    September 16, 2012
    Report Date
    October 8, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LUMBAR DRAIN PLACEMENT, RESISTANCE WAS MET. THE NEEDLE WAS THEN PULLED OUT AND PROVIDER PROCEEDED TO SLOWLY PULL BACK ON THE CATHETER. BECAUSE NO CEREBROSPINAL FLUID WAS OBTAINED, THE DECISION WAS MADE TO COMPLETELY PULL OUT THE CATHETER AND RESTART THE PROCESS. AT THIS POINT IT WAS NOTED THAT THE DISTAL END OF THE CATHETER WAS FRACTURED. THE TIP WAS REPORTEDLY RETAINED. AN ATTEMPT WAS MADE TO USE ANOTHER CATHETER FROM THE SAME LOT. THIS WAS ALSO FOUND TO BE WEAK AND WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC LUMBAR DRAINAGE KIT WITH 120 ML CHAMBER JXG MEDTRONIC NEUROSURGERY 12410692

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other