BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIO AT

    MDR report key: 20159226 · Received September 6, 2024

    Report

    Report Number
    3007208829-2024-00443
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 9, 2024
    Report Date
    June 23, 2025
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    QYX
    UDI-DI
    00869770000210
    PMA / PMN Number
    K163512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT REVEALED THE PATIENT HAD UNDERGONE MEDICAL TESTING (ECHO CARDIOGRAM AND X-RAYS) PRIOR TO PATCH APPLICATION ON DAY 0. SUBSEQUENTLY, THE PATCH WAS APPLIED WITHOUT ISSUE LATER THAT SAME DAY. ON DAY 7, AN ACTIONABLE ARRHYTHMIA DID NOT TRANSMIT, RESULTING IN A DELAYED MDN. ON DAY 14, THE PATIENT CONTACTED IRHYTHM TO REPORT THEIR HOSPITALIZATION AND TO REQUEST AN EXPEDITED PATIENT REPORT FOR THEIR HEALTHCARE PROVIDER (HCP) TO REVIEW. THE PATIENT ALSO WANTED TO KNOW HOW TO RETURN THE ZIO AT. THE ZIO AT DEVICE WAS RETURNED TO IRHYTHM, AND THE CLINICAL DATA WAS DOWNLOADED. A REVIEW OF THE CLINICAL DATA FOUND THAT THE PATIENT WORE THE ZIO AT DEVICE FOR THE 14-DAY PRESCRIBED WEAR PERIOD. IRHYTHM BECAME AWARE OF THE ARRHYTHMIA WHILE PREPARING THE FINAL REPORT AND NOTIFIED THE HCP ON 18. THE INVESTIGATION CONCLUDED THAT THE ALGORITHM DID NOT DETECT THE ARRHYTHMIA DURING WEAR; HOWEVER, IT WAS DETECTED DURING POST-WEAR PROCESSING. THE EXACT CAUSE OF THE PATIENT¿S HOSPITALIZATION COULD NOT BE DETERMINED; HOWEVER, A CARDIAC-RELATED EVENT CANNOT BE RULED OUT. 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 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 PATIENT REPORTED PASSING OUT AND HITTING THEIR HEAD AND, AS A RESULT, WAS TAKEN VIA AMBULANCE TO THE HOSPITAL. REPORTEDLY, BRAIN SCANS WERE PERFORMED AND CAME BACK NEGATIVE FOR ANY BLEEDING. THE MEDICAL DOCTOR HAS NOT BEEN ABLE TO DETERMINE THE CAUSE OF THE PATIENT'S SYNCOPE EPISODE. IT IS UNKNOWN IF THE PATIENT WAS TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864882 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA QYX IRHYTHM TECHNOLOGIES, INC 00869770000210

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization