BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 20619465 · Received November 6, 2024

    Report

    Report Number
    3007208829-2024-00479
    Event Type
    Death
    Date Received
    November 6, 2024
    Date of Event
    October 3, 2024
    Report Date
    June 20, 2025
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    QYX
    UDI-DI
    00869770000210
    PMA / PMN Number
    K163512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT INDICATED THAT ON (B)(6) 2024, THE ¿BASELINE REPORT¿ (INITIAL TRANSMISSION REPORT) WAS RECEIVED, AND THE DEVICE TRIGGERED A SERVICE MONITORING TICKET SHOWING NO CONNECTION FOR A 4-HOUR PERIOD. THE DEVICE RECONNECTED BUT CONTINUED TO EXPERIENCE INTERMITTENT CONNECTIVITY ISSUES FROM (B)(6); HOWEVER, THE PATIENT¿S DAILY REPORT SHOWS RECORDED TRANSMISSIONS DURING THIS TIME. AN ACTIONABLE ARRHYTHMIA WAS IDENTIFIED ON (B)(6) 2024, AND PER STANDARD PROTOCOL, IRHYTHM NOTIFIED THE ACCOUNT APPROPRIATELY AND WAS INFORMED THAT THE ON-CALL ELECTROPHYSIOLOGIST WOULD BE PAGED AND THAT THE PATIENT HAD EXPIRED. AVAILABLE CLINICAL DATA SHOWED THE PATIENT WORE THE DEVICE FOR APPROXIMATELY 4 DAYS OF THE 14-DAY PRESCRIBED WEAR PERIOD. A REVIEW OF THE PATIENT¿S DAILY REPORTS SHOWED TRANSMISSION FROM (B)(6). THE ZIO AT WAS NOT RETURNED TO IRHYTHM FOR EVALUATION; THEREFORE, IRHYTHM CANNOT CONFIRM IF A DEVICE MALFUNCTION OCCURRED. HOWEVER, BASED ON THE AVAILABLE INFORMATION, NO KNOWN MISSED OR MISCLASSIFIED MDNS LIKELY ATTRIBUTED TO OR CAUSED THE EVENT. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. THIS EVENT IS BEING REPORTED PER 21CFR803 AS A SERIOUS INJURY. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY RHYTHM THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED. THESE TERMS ARE INCLUDED IN FORM FDA 3500A AND ARE FIXED TERMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING.

    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. IRHYTHM ATTEMPTED TO GATHER MORE INFORMATION ABOUT THE CAUSE OF DEATH FROM THE ACCOUNT, BUT NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999439 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Death