BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 9713134 · Received February 14, 2020

    Report

    Report Number
    3002968685-2020-00009
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 15, 2020
    Report Date
    February 14, 2020
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340134
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A BASIC TRIAL PROCEDURE, THERE WAS AN ISSUE WITH THE BASIC TRIAL CABLE (BTC). IMPEDANCE LEVEL SHOWED A SHORT CIRCUIT. THE BASIC TRIAL CABLE (BTC) WAS REPLACED AND EVERYTHING WORKED FINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176045 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1701 AK1F690001 10810005340134

    Patients

    Seq Age Sex Outcome Treatment
    1