BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 9656204 · Received February 1, 2020

    Report

    Report Number
    3002968685-2020-00004
    Event Type
    Malfunction
    Date Received
    February 1, 2020
    Date of Event
    January 2, 2020
    Report Date
    March 27, 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
    OH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    SEE SECTION H, NUMBER 6, EVENT PROBLEM AND EVALUATION CODES.

    Description of Event or Problem · 0

    SEE SECTION H, NUMBER 6, EVENT PROBLEM AND EVALUATION CODES.

    Additional Manufacturer Narrative · 1

    RESULTS PENDING COMPLETION OF INVESTIGATION. DEVICE DISLODGED OR DISLOCATED. DELAY TO TREATMENT/THERAPY. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. ANALYSIS OF PRODUCTION RECORDS. THIS IS AN INITIAL SUBMISSION AS WE ARE PENDING COMPLETION OF THE DEVICE EVALUATION AND INVESTIGATION.

    Description of Event or Problem · 1

    THE PNE LEAD BROKE FROM THE BASIC TRIAL CABLE (BTC) AND A METAL PIN WAS BEING INSERTED TO CONNECT IT. AFTER THE PNE LEAD BROKE, A NEW PNE LEAD HAD TO BE PLACED ON THE SAME SIDE AS THE ORIGINAL. NO STIMULATION COULD BE DELIVERED. THE BTC WAS THEN REPLACED AND THE SYSTEM WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119980 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1701 AK1JC91001 10810005340134

    Patients

    Seq Age Sex Outcome Treatment
    1 BASIC TRIAL CABLE, MODEL 9014| BASIC TRIAL CABLE, MODEL 9014| BASIC TRIAL CABLE, MODEL 9014