BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 9713456 · Received February 14, 2020

    Report

    Report Number
    3002968685-2020-00010
    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
    MS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTOR REQUESTED TO ADJUST PATIENT'S PNE LEADS DUE TO A LOSS IN STIMULATION WHICH REQUIRED REMOVING THE DRESSING. THE BASIC TRIAL CABLE (BTC) WAS DIFFICULT TO REMOVE FROM THE DRESSING AND REQUIRED PULLING. THERE WAS CONCERN THE BTC WAS DAMAGED FROM PULLING, BUT NO VISIBLE DAMAGE WAS PRESENT. THE BTC WAS REPLACED. THERE WERE NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176939 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1701 AK1HA91003 10810005340134

    Patients

    Seq Age Sex Outcome Treatment
    1