BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIO AT

    MDR report key: 15621514 · Received October 18, 2022

    Report

    Report Number
    3007208829-2022-00050
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    September 22, 2022
    Report Date
    September 22, 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

    THE PATIENT WAS HOSPITALIZED AFTER APPROXIMATELY 1 DAY OF THE PRESCRIBED 14-DAY WEAR PERIOD. AN EPISODE OF SLOW ATRIAL FIBRILLATION OCCURRED ON (B)(6) 2022 AT 10:43:31AM DURING THE WEAR PERIOD BUT WAS ONLY PARTIALLY TRANSMITTED TO IRHYTHM SERVERS. THE COMPLETE EPISODE WAS CAPTURED ON THE FINAL REPORT. THE TIMELINE OF EVENTS IS AS FOLLOWS: THE PATIENT WAS ORIGINALLY ADMITTED TO THE HOSPITAL AT AN UNKNOWN DATE, WITH SYMPTOMS WHICH INCLUDED POSSIBLE DYSARTHRIA AND PRE-SYNCOPE, AND INABILITY MOVE FROM A SITTING TO STANDING POSITION. THE PATIENT WAS DISCHARGED ON (B)(6) 2022 AND HAD A ZIO AT DEVICE PLACED IN THEIR PHYSICIANS OFFICE ON THE SAME DAY. THE PATIENT'S SYMPTOMS CONTINUED AND THE PATIENT WAS AGAIN HOSPITALIZED ON (B)(6) 2022 DUE TO A SYNCOPAL EPISODE. THE PATIENT REMOVED THE DEVICE ON (B)(6) 2022 DUE TO BEING IN HOSPITAL. ON 19-SEP-2022 THE DEVICE WAS RETURNED TO IRHYTHM AND THE DATA WAS PROCESSED FOR INCLUSION ON THE FINAL REPORT. AN ANALYSIS OF THE DIAGNOSTIC DATA WAS COMPLETED 13-OCT-2022 AND CONFIRMED THAT GATEWAY CELL CONNECTIONS WERE INTERRUPTED WHICH COULD HAVE ATTRIBUTED TO THE MISSED TRANSMISSION. THE CAUSE OF THE INTERRUPTED COMMUNICATION WAS ATTRIBUTED TO CELLULAR CONNECTIVITY ISSUES. NO HEALTH CONSEQUENCES ARE ATTRIBUTED TO THE MALFUNCTION AS THE PATIENT WAS ALREADY IN THE HOSPITAL WHEN THE MALFUNCTION OCCURRED. THE ZIO AT ECG AMBULATORY MONITORING SYSTEM IS INTENDED TO CAPTURE, ANALYZE AND REPORT SYMPTOMATIC AND ASYMPTOMATIC CARDIAC EVENTS AND CONTINUOUS ELECTROCARDIOGRAM (ECG) INFORMATION FOR LONG-TERM MONITORING. THE ZIO AT IS NOT INDICATED FOR IN-HOSPITAL MONITORING OF CRITICAL CARE PATIENTS.

    Description of Event or Problem · 0

    THE PATIENT SUFFERED A CARDIAC EVENT DURING MOBILE CARDIAC TELEMETRY MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307755 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Hospitalization| O