BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM

    MDR report key: 10903000 · Received November 25, 2020

    Report

    Report Number
    10903000
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 28, 2020
    Report Date
    November 4, 2020
    Manufacturer
    SPINAL MODULATION, INC.
    Product Code
    PMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON PLACED TRIAL LEAD DURING SURGERY TO RIGHT LUMBAR 5-SACRAL 1 AREA, SURGEON WAS UNABLE TO REMOVE INNER WIRE DUE TO OUTER SHEATH BEING KINKED. SURGEON REMOVED INNER WIRE AND OUTER SHEATH OF TRIAL LEAD AND REPLACED IT WITH A BRAND NEW ONE. NO ADVERSE EFFECTS TO PATIENT AT THIS TIME PER SURGEON. MANUFACTURER REPRESENTATIVE AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369143 AXIUM DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF PMP SPINAL MODULATION, INC. MN10350-90A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA