BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 9677078 · Received February 6, 2020

    Report

    Report Number
    3002968685-2020-00006
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    November 18, 2019
    Report Date
    February 6, 2020
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340127
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE FORAMEN NEEDLE OVER THE PNE LEAD, THE PNE LEAD BECAME STUCK IN THE NEEDLE AND THEN STRETCHED. THE PHYSICIAN THEN REMOVED THE ENTIRE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140480 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1901 10810005340127

    Patients

    Seq Age Sex Outcome Treatment
    1