BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 16241125 · Received January 25, 2023

    Report

    Report Number
    3007208829-2023-00007
    Event Type
    Death
    Date Received
    January 25, 2023
    Date of Event
    February 5, 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

    THIS MDR SUBMISSION REPRESENTS AN INCIDENT WHERE THE PATIENT EXPIRED. THE INVESTIGATION REVEALED THE DEVICE WAS APPLIED ON (B)(6) 2022, BUT THE GATEWAY WAS NEVER ACTIVATED SO NO DATA COULD BE TRANSMITTED. AN ATTEMPT TO CONTACT THE PATIENT WAS MADE ON (B)(6) 2022 TO RECTIFY WHY NO BASELINE TRANSMISSION HAD BEEN RECEIVED. CONTACT WAS MADE, BUT FOR THE WRONG PATIENT DUE TO A REGISTRATION ERROR AT THE ACCOUNT. THE ACCOUNT WAS NOTIFIED THE SAME DAY. NOT UNTIL (B)(6) 2022 DID THE ACCOUNT NOTIFY OF THE PATIENT¿S DEATH AT WHICH TIME WE INFORMED THE ACCOUNT AGAIN OF THE PATIENT MIX UP AND NO GATEWAY ACTIVATION. THE PATIENT PASSED AWAY ON (B)(6) 2022. THE DEVICE WAS RETURNED ON 12FEB2022, AT WHICH TIME THE STORED DATA WAS ANALYZED. A REVIEW OF THE LOGS INDICATES THE GATEWAY WAS ACTIVATED ON (B)(6) 2022, AT WHICH TIME STORED TRANSMISSIONS WERE SENT SHOWING A BASELINE TRANSMISSION ON (B)(6) 2022.

    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) 2022, BUT DUE TO THE NEW CRITERIA, THE AWARENESS DATE IS 27DEC2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175934 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Death