BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM

    MDR report key: 7154011 · Received December 29, 2017

    Report

    Report Number
    7154011
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    December 5, 2017
    Report Date
    December 13, 2017
    Manufacturer
    SPINAL MODULATION INC.
    Product Code
    PMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE WIRE WOULD NOT PULL OUT OF THE SHEATH ONCE IMPLANTED. THE ENTIRE IMPLANT WAS REMOVED AND A NEW LEAD WAS IMPLANTED. PER MD, THIS CAUSED ABOUT AN HOUR EXTRA SURGERY TIME FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934586 AXIUM KIT, IMPLANT LEAD PMP SPINAL MODULATION INC. MN10450-50A AB2346

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other