BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET EXTERNAL DRAINAGE LUMBAR W/GWR & TOUHY NEEDLE

    MDR report key: 16700891 · Received April 7, 2023

    Report

    Report Number
    16700891
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    March 14, 2023
    Report Date
    March 27, 2023
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD THE LUMBAR DRAIN REMOVED AT THE BEDSIDE BY THE NEUROSURGEON WITH EVIDENCE THAT THE CATHETER TIP HAD TRANSECTED LONGITUDINALLY IN MULTIPLE PIECES. CT REVEALED A RADIOPAQUE FOREIGN BODY WITHIN THE SPINAL CORD AT LEVEL L2-L3 WITH MULTIPLE PROJECTIONS EXTENDING INFERIORLY. THE PATIENT WAS TAKEN FOR A LAMINECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441265 SET EXTERNAL DRAINAGE LUMBAR W/GWR & TOUHY NEEDLE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG NATUS MEDICAL INCORPORATED 118000544297

    Patients

    Seq Age Sex Outcome Treatment
    1 16425 DA Male Required Intervention| O