BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 15912222 · Received December 3, 2022

    Report

    Report Number
    3007208829-2022-00055
    Event Type
    Death
    Date Received
    December 3, 2022
    Date of Event
    October 18, 2021
    Report Date
    November 18, 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 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. BELOW IS A TIMELINE OF EVENTS SUPPORTED BY DATA OBTAINED FROM THE SUBJECT DEVICE: ON B)(6) 2021, A ZIO® AT HOME ENROLLMENT DEVICE WAS SHIPPED TO THE PATIENT. AN INBOUND CALL FROM THE PATIENT¿S CAREGIVER WAS RECEIVED ON B)(6) 2021 WHO STATED THE PATIENT WAS TAKEN TO THE HOSPITAL. IT IS UNKNOWN FOR WHAT REASON THE PATIENT WENT TO THE HOSPITAL OR IF THE PATIENT WAS ADMITTED. ON B)(6) 2021, THE DEVICE REACHED ITS LIMIT OF 500 TRANSMISSIONS. THE ACCOUNT WAS NOTIFIED THE DEVICE HAD REACHED THE ASYMPTOMATIC TRANSMISSION LIMIT ON B)(6) 2021 AND A REPLACEMENT DEVICE WAS DISPATCHED TO THE PATIENT OVERNIGHT. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PATIENT AND THE ACCOUNT TO NOTIFY THAT THE PATIENTS REPLACEMENT DEVICE WAS NOT ACTIVE OR TRANSMITTING, AND ON (B)(6) 2022 THE PATIENT EXPIRED WHILE WEARING THE INITIAL DEVICE. BOTH DEVICES WERE RETURNED TO IRHYTHM; THE REPLACEMENT DEVICE WAS RECEIVED UNOPENED AS THE DEVICE WAS NEVER WORN BY THE PATIENT. INVESTIGATION INTO THE REPORTED ISSUE HAS CONFIRMED THAT THE WORN DEVICE DID NOT MALFUNCTION. EACH DEVICE WILL TRANSMIT UP TO 500 ASYMPTOMATIC CARDIAC EVENTS. THIS CONSTRAINT IS NECESSARY TO PRESERVE BATTERY LIFE FOR THE FULL INTENDED WEAR-PERIOD. PATIENT-TRIGGERED SYMPTOMATIC TRANSMISSIONS ARE STILL ABLE TO BE TRANSMITTED BEYOND THIS LIMIT BY PRESSING THE LARGE CENTRAL BUTTON LOCATED ON THE OUTER DEVICE HOUSING. THIS DOES NOT CONSTITUTE A MALFUNCTION OF THE DEVICE AS THE DEVICE IS FUNCTIONING AS DESIGNED.

    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
    2112508 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death