BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 15459899 · Received September 20, 2022

    Report

    Report Number
    3007208829-2022-00042
    Event Type
    Death
    Date Received
    September 20, 2022
    Date of Event
    August 1, 2022
    Report Date
    October 17, 2022
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    DSI
    PMA / PMN Number
    K163512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED TO THE INVESTIGATION FACILITY AND AN INVESTIGATION IS UNDERWAY. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022 THE PATIENTS ZIO AT DEVICE WAS PLACED. ON 01AUG2022, IRHYTHM RECEIVED AN AUTOMATED TICKET INDICATING POSSIBLE CONNECTIVITY ISSUES WITH THE INVOLVED DEVICE. THE PATIENT WAS CONTACTED TO TROUBLESHOOT AND WAS DETERMINED TO LIKELY BE EXPERIENCING CELL-CONNECTIVITY ISSUES ASSOCIATED WITH CARRIER COVERAGE IN THE AREA. DURING THE CALL, THE PATIENT WAS ADVISED TO CONTINUE WEARING THE DEVICE AND TO KEEP THE GATEWAY WITH THEM IF TRAVELING, AS THE DEVICE IS DESIGNED BACKUP UNSENT NOTIFICATIONS IN ORDER TO BE SENT IN THE EVENT THAT IT IS ABLE TO OBTAIN A CELLULAR SIGNAL. IRHYTHM AGENTS ATTEMPTED TO REACH THE ACCOUNT TO NOTIFY THEM THAT THE CUSTOMER WAS EXPERIENCING COVERAGE ISSUES AND THIS IS LIKELY THE REASON THEY WERE RECEIVING NO NOTIFICATIONS AND HAD NOT RECEIVED A BASELINE REPORT; HOWEVER NO CONTACT WAS MADE. THE DEVICE CONTINUED TO WORK AS AN ECG MONITOR, BUT LACKED CELLULAR TRANSMISSION FUNCTIONALITY. NO FURTHER TRANSMISSIONS WERE RECEIVED AFTER 01AUG2022. ON 17AUG2022, THE DEVICE WAS RETURNED TO IRHYTHM, AND THE DATA WAS PROCESSED FOR INCLUSION ON THE FINAL REPORT. ON 22AUG2022, IRHYTHM WAS MADE AWARE BY THE ACCOUNT THAT THE PATIENT WAS FOUND BY EMS WITH PULSELESS VT AND TAKEN TO THE HOSPITAL (DATE OF EVENT NOT KNOWN AS IT OCCURRED AFTER THE WEAR-PERIOD). ON 26AUG2022, THE ACCOUNT CONFIRMED THE PATIENT EXPIRED AT AN UNKNOWN DATE. AN ANALYSIS OF THE DIAGNOSTIC DATA WAS COMPLETED 14OCT2022 AND CONFIRMED THE GATEWAY BECAME IDLE AND CEASED CONNECTIONS ON 29JUL2022. THE ACCOUNT ALLEGED THAT THE OUTCOME COULD HAVE BEEN PREVENTED BY NOTIFICATION OF THE MISSED MDN. THE ZIO AT DEVICE IS NOT A INTENDED FOR MONITORING OF CRITICALLY ILL PATIENTS.

    Description of Event or Problem · 0

    THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT WAS NOT DETECTED BY THE DEVICE¿S AUTOMATIC DETECTION FEATURE AND WAS SUBSEQUENTLY NOT TRANSMITTED DURING THE WEAR-PERIOD.  THE EVENT WAS FOUND WHEN COMPILING THE FINAL, FULL-DATA REPORT BY CERTIFIED CARDIOGRAPHIC TECHNICIAN.  THE PATIENT WAS HOSPITALIZED AND ON (B)(6) 2022, IT WAS CONFIRMED BY THE ACCOUNT THAT THE PATIENT HAD EXPIRED DUE TO VENTRICULAR TACHYCARDIA. THE DATE OF THE PATIENTS DEATH IS UNKNOWN.

    Description of Event or Problem · 0

    THE PATIENT SUFFERED A FATAL CARDIAC EVENT DURING MOBILE CARDIAC TELEMETRY MONITORING. AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) OCCURRED DURING THE WEAR-PERIOD BUT WAS NOT TRANSMITTED TO IRHYTHM SERVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566651 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Death