BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO AT

    MDR report key: 21044477 · Received December 30, 2024

    Report

    Report Number
    3007208829-2024-00517
    Event Type
    Death
    Date Received
    December 30, 2024
    Date of Event
    November 28, 2024
    Report Date
    January 29, 2025
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    QYX
    UDI-DI
    00869770000210
    PMA / PMN Number
    K240029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THIS COMPLAINT REVEALED THAT THE PATIENT WAS PRESCRIBED A ZIO AT DEVICE FOR A 14-DAY PRESCRIBED WEAR PERIOD. THE ZIO AT DEVICE WAS RETURNED TO IRHYTHM ON DAY 18 AND THE CLINICAL DATA WAS DOWNLOADED. ON DAYS 2 AND 9 OF WEAR, THE ZIO AT DEVICE RECORDED ARRHYTHMIAS, HOWEVER AFTER A MEDICAL ASSESSMENT CONDUCTED BY IRHYTHM¿S CHIEF MEDICAL & SCIENTIFIC OFFICER, IT WAS CONCLUDED THAT THE ARRHYTHMIAS DID NOT MEET THE CRITERIA FOR TRANSMISSIONS, AND THEREFORE THERE WAS NO DEVICE MALFUNCTION. THE END-OF-LIFE EVENT OCCURRED SIX DAYS AFTER THE DEVICE WAS REMOVED. THEREFORE, IT WAS DETERMINED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S OUTCOME AS THERE WAS NOTHING IN THE REPORT THAT WOULD CONCLUDE A CARDIAC CAUSE OF DEATH THAT WAS MISSED BY THE DEVICE. IRHYTHM MADE SEVERAL ATTEMPTS TO GATHER ADDITIONAL INFORMATION BUT NO RESPONSE WAS RECEIVED. THIS EVENT IS BEING REPORTED PER 21CFR 803 AS AN ADVERSE EVENT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY IRHYTHM THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED. THESE TERMS ARE INCLUDED IN FORMFDA 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

    A REVIEW OF THIS COMPLAINT REVEALED THAT THE PATIENT WAS PRESCRIBED A ZIO AT DEVICE FOR A 14-DAY PRESCRIBED WEAR PERIOD. THE ZIO AT DEVICE WAS RETURNED TO IRHYTHM ON NOVEMBER 30, 2024 AND THE CLINICAL DATA WAS DOWNLOADED. ON DAY 2 OF WEAR, THE ZIO AT DEVICE RECORDED AN ACTIONABLE ARRHYTHMIA THAT TRANSMITTED DURING WEAR BUT WAS MISINTERPRETED BY THE CERTIFIED CARDIOGRAPHIC TECHNICIAN (CCT). ON DAY 9 OF WEAR, THE ZIO AT DEVICE RECORDED ANOTHER ACTIONABLE ARRHYTHMIA HOWEVER THIS EVENT DID NOT TRANSMIT DURING WEAR DUE TO THE ALGORITHM. AVAILABLE DEVICE DATA INDICATES THAT THE PATCH WAS REMOVED FROM THE PATIENT ON DAY 10. THE END-OF-LIFE EVENT OCCURRED ON (B)(6) 2024, WHICH WAS SIX DAYS AFTER THE DEVICE WAS REMOVED. IRHYTHM MADE SEVERAL ATTEMPTS TO GATHER ADDITIONAL INFORMATION BUT NO RESPONSE WAS RECEIVED. THE INVESTIGATION IS ONGOING AND THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY UPON COMPLETION. THE AT CLINICAL REFERENCE MANUAL STATES IN THE ¿INDICATIONS FOR USE¿ SECTION THAT ¿THE REPORTS ARE PROVIDED FOR REVIEW BY THE INTENDED USER TO RENDER A DIAGNOSIS BASED ON CLINICAL JUDGMENT AND EXPERIENCE.¿ THIS EVENT IS BEING REPORTED PER 21CFR 803 AS A ADVERSE EVENT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY IRHYTHM 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.

    Description of Event or Problem · 0

    THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION CONCLUDED THAT THE ALGORITHM DID NOT DETECT THE ARRHYTHMIA DURING WEAR. THE HEALTHCARE PROVIDER (HCP) WAS IMMEDIATELY NOTIFIED, AND IRHYTHM LEARNED THAT THE PATIENT EXPIRED SIX DAYS AFTER THE DEVICE WAS REMOVED. IRHYTHM ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CAUSE OF DEATH, BUT WITH NO RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128130 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Death