BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT PATCH

    MDR report key: 15481268 · Received September 24, 2022

    Report

    Report Number
    3007208829-2022-00041
    Event Type
    Death
    Date Received
    September 24, 2022
    Date of Event
    October 17, 2021
    Report Date
    September 29, 2023
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC.
    Product Code
    DSI
    UDI-DI
    00869770000210
    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 EXPIRED ON (B)(6) 2021, AFTER APPROXIMATELY 13.33 DAYS OF THE PRESCRIBED 14-DAY WEAR-PERIOD. THERE WERE ECG TRANSMISSIONS SENT TO THE PRESCRIBING PHYSICIAN AS PART OF ROUTINE AND DAILY REPORTS ON OCTOBER 8TH, 11TH, AND 13TH, 2021. THESE REPORTS INCLUDED EPISODES OF VENTRICULAR TACHYCARDIA (VT) WHICH WERE APPROPRIATELY DETECTED AND TRANSMITTED BY THE MEDICAL DEVICE TO THE INDEPENDENT TESTING FACILITY (IDTF). ACCORDING TO IRHYTHM TECHNOLOGIES, INC.'S CHIEF MEDICAL AND CHIEF SCIENTIFIC OFFICER, THE TIME FOR MEDICAL INTERVENTION WOULD HAVE BEEN APPROPRIATE AS EARLY AS OCTOBER 8, 2021. INVESTIGATION INTO THE REPORTED ISSUE HAS CONFIRMED THE DEVICE DID NOT MALFUNCTION. THE AVAILABLE EVIDENCE AND INVESTIGATION DOES NOT REASONABLY SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED DEATH. SUMMARY REPORTS ARE PROVIDED FOR REVIEW BY THE INTENDED USER TO RENDER A DIAGNOSIS BASED ON CLINICAL JUDGMENT AND EXPERIENCE. THE ZIO AT ECG MONITORING SYSTEM IS NOT INTENDED FOR USE ON CRITICAL CARE PATIENTS. THIS MDR IS BEING FILED DUE TO A RETROSPECTIVE REVIEW OF COMPLAINTS PER NEW ESTABLISHED CRITERIA FOR ADVERSE EVENT REPORTING. THE AWARENESS DATE REPRESENTS THE DATE THIS COMPLAINT WAS IDENTIFIED AS MEETING THE NEW CRITERIA. A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD NEW SIGNIFICANT INFORMATION BE OBTAINED RELATIVE TO THIS EVENT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579517 ZIO AT PATCH DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC. 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other| D