BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 18822196 · Received March 1, 2024

    Report

    Report Number
    3007208829-2024-00094
    Event Type
    Death
    Date Received
    March 1, 2024
    Date of Event
    January 31, 2024
    Report Date
    June 24, 2025
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    QYX
    UDI-DI
    00869770000210
    PMA / PMN Number
    K163512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED IN RESPONSE TO THE FDA NOTIFICATION RECEIVED ON SEPTEMBER 26, 2024, CONCERNING MISSING UDI NUMBERS IN MDR SUBMISSIONS FROM OCTOBER 2023 THROUGH DECEMBER 2024. IN RESPONSE TO THIS ISSUE, IRHYTHM CONDUCTED AN INVESTIGATION AND IDENTIFIED A SYSTEM PROCESSING ERROR, WHICH HAS NOW BEEN RESOLVED. PLEASE SEE THE UPDATE IN SECTION D4.

    Description of Event or Problem · 0

    THE PATIENT EXPIRED DURING THEIR PRESCRIBED ZIO AT WEAR PERIOD. FOLLOW-UP WITH THE PATIENT'S HEALTHCARE PROVIDER REVEALED THAT THE PATIENT HAD EXPERIENCED A VASOVAGAL RESPONSE LEADING TO CARDIAC AND RESPIRATORY ARREST. DESPITE THE NURSING STAFF'S EFFORTS TO REVIVE HER, THEY WERE UNSUCCESSFUL. BASED ON THE AVAILABLE DATA THERE WAS NO EVIDENCE THAT THE DEVICE CAUSED THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227988 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Death