BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 16142575 · Received January 11, 2023

    Report

    Report Number
    3007208829-2023-00002
    Event Type
    Death
    Date Received
    January 11, 2023
    Date of Event
    January 1, 2021
    Report Date
    December 16, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AT PATCH AND GATEWAY WERE RETURNED, AND NO MALFUNCTION WAS IDENTIFIED. THE PATIENT EXPERIENCED A LIFE-THREATENING ARRHYTHMIA WHICH WAS NOT TRANSMITTED TO IRHYTHM¿S IDTF (42CFR410) UNTIL AFTER THE PATIENT EXPIRED. THE TIME DISCREPANCY BETWEEN THE REAL TIME OCCURRENCES AND THE DATA RECEIVED BY IRHYTHM WAS MOST LIKELY DUE TO THE PATIENT NOT BEING NEAR THE GATEWAY WHEN ADMITTED TO THE HOSPITAL. NOT UNTIL THE PATCH AND GATEWAY WERE IN PROXIMITY WERE THE EVENTS TRANSMITTED, WHICH WAS AFTER THE EOL EVENT.

    Description of Event or Problem · 0

    THIS MDR IS BEING FILED AS THE RESULT OF AN UPDATE TO OUR ADVERSE EVENT REPORTING PROCEDURE. THE EVENT OCCURRED ON (B)(6) 2021, BUT DUE TO THE NEW CRITERIA, THE AWARENESS DATE IS 16DEC2022. THE PATIENT PASSED WAY WHILE WEARING ZIO AT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178743 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Death