BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXONICS

    MDR report key: 10376919 · Received August 6, 2020

    Report

    Report Number
    3002968685-2020-00065
    Event Type
    Death
    Date Received
    August 6, 2020
    Date of Event
    July 10, 2020
    Report Date
    August 6, 2020
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AXONICS WAS MADE AWARE ON 07/21/2020 THAT A PATIENT HAD UNDERGONE A FULL IMPLANT PROCEDURE ON (B)(6) 2020. THE PROCEDURE WAS PERFORMED UNDER MAC ANESTHESIA AT A SURGERY CENTER. THE CASE LASTED APPROXIMATELY 15 MINUTES AND THERE WERE NO SURGICAL ISSUES. THE CRNA, HOWEVER, STRUGGLED WITH THE OXYGEN LEVELS DURING THE ENTIRE CASE AND AT THE TIME OF CLOSING, THE PATIENT'S OXYGEN SATURATION LEVEL WAS NOTED TO BE VERY LOW. THEY WERE IMMEDIATELY FLIPPED TO THE SUPINE POSITION AND SUBSEQUENTLY CODED. THE PATIENT WAS RESUSCITATED FOR 7 MINUTES BEFORE THEY HAD A RETURN OF CARDIAC FUNCTION. THE PATIENT WAS TRANSPORTED TO A HOSPITAL WHERE THEY WERE TAKEN TO THE CATH LAB. DURING THE CATH PROCEDURE, PATIENT CODED AGAIN AND WAS DOWN FOR 22 MINUTES BEFORE BEING RESUSCITATED. THE PATIENT WAS TRANSPORTED TO THE ICU AND PLACED ON A VENTILATOR, BUT WAS UNRESPONSIVE. THE FAMILY MADE THE DECISION ON (B)(6) 2020 TO WITHDRAW LIFE-SUPPORT AND PATIENT PASSED AWAY SHORTLY AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836282 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death