BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 16211913 · Received January 19, 2023

    Report

    Report Number
    3007208829-2023-00005
    Event Type
    Death
    Date Received
    January 19, 2023
    Date of Event
    December 23, 2022
    Report Date
    December 27, 2022
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    DSI
    PMA / PMN Number
    K163512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN COMPILING THE FINAL REPORT, AN ARRHYTHMIA WHICH MET NOTIFICATION CRITERIA (MDN) FOR SLOW ATRIAL FIBRILLATION (SLOW AF) WAS FOUND. THE MDN WAS DELAYED AS IT WAS NOT TRANSMITTED TO IRHYTHM SERVERS DURING THE WEAR-PERIOD. WHEN ACCOUNT WAS CONTACTED TO PROVIDE NOTIFICATION OF THE MISSED EVENT, IRHYTHM WAS INFORMED THAT THE PATIENT HAD EXPIRED. THE ACCOUNT STATED THE CAUSE OF DEATH WAS UNKNOWN. EACH DEVICE IS INTENDED TO BE WORN FOR A 14-DAY PERIOD AND IS CAPABLE OF TRANSMITTING 500 ASYMPTOMATIC EPISODES. THE FIRST DEVICE WAS REGISTERED (B)(6) 2022 IN CLINIC BUT WAS NOT ACTIVATED UNTIL (B)(6) 2022 DESPITE MULTIPLE ATTEMPTS TO REACH THE PATIENT AND ACCOUNT. ON THE (B)(6) 2022, IRHYTHM DISPATCHED A REPLACEMENT DEVICE, AS THE FIRST DEVICE WAS APPROACHING ITS TRANSMISSION LIMIT OF 500 ASYMPTOMATIC NOTIFICATIONS, AND THE FIRST DEVICE WAS REMOVED THE NEXT DAY ON (B)(6) 2022 (WORN FOR 25 DAYS). THE SECOND DEVICE (DELIVERED ON (B)(6) 2022) WAS RETURNED UNUSED. DUE TO THE LIMITED INFORMATION AVAILABLE, UNINTENDED USE ERROR CANNOT BE RULED AS A POTENTIAL CONTRIBUTING FACTOR TO THE REPORTED DEATH. A DEVICE EVALUATION OF THE WORN DEVICE WAS COMPLETED, AND NO FUNCTIONAL ISSUES WERE OBSERVED.

    Description of Event or Problem · 0

    THE PATIENT EXPIRED WHILE USING ZIO AT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113642 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death