BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 10039477 · Received May 8, 2020

    Report

    Report Number
    3002968685-2020-00039
    Event Type
    Malfunction
    Date Received
    May 8, 2020
    Date of Event
    April 9, 2020
    Report Date
    July 1, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    SEE SECTION H, NUMBER 6, EVENT PROBLEM AND EVALUATION CODES AND SECTION H, NUMBER 10, ADDITIONAL MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 1

    PENDING DEVICE RETURN FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A PNE LEAD ON (B)(6) 2020. WHEN PATIENT LEFT THE HOSPITAL, THE PATIENT COULD NOT FEEL THE STIMULATION AND WENT BACK. THE NURSE SAW AN IMPEDANCE ERROR. THE NURSE REPLACED THE TRIAL STIMULATOR, GROUND CABLE, AND BASIC TRIAL CABLE AND THIS APPEARED TO HAVE RESOLVED THE ISSUE. THE NEXT DAY, THE ISSUE REOCCURRED AND THE PATIENT RETURNED TO THE HOSPITAL. THE DOCTOR WAS UNABLE TO RESOLVE THE ISSUE. ON (B)(6)2020, THE REPRESENTATIVE AND DOCTOR MET WITH THE PATIENT AND THE REPRESENTATIVE WAS ABLE TO CONFIRM AN IMPEDANCE ERROR ON THEIR CLINICIAN PROGRAMMER. THE REPRESENTATIVE CHECKED THE CONNECTION TO THE TRIAL STIMULATOR AND CONNECTION BETWEEN THE PNE LEAD AND BASIC TRIAL CABLE, BUT RESULTS REMAINED THE SAME. THE REPRESENTATIVE REPLACED THE GROUND PAD, BUT NO CHANGES. AS THE ISSUE WAS UNABLE TO BE RESOLVED, THE DOCTOR DECIDED TO EXPLANT THE PNE LEAD. PER REPRESENTATIVE, ONLY THE BASIC TRIAL CABLE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502398 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1701 10810005340134

    Patients

    Seq Age Sex Outcome Treatment
    1