BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLE WATCH

    MDR report key: 21038182 · Received December 27, 2024

    Report

    Report Number
    MW5164056
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    December 18, 2024
    Report Date
    December 18, 2024
    Manufacturer
    APPLE INC.
    Product Code
    QDA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I OWN AN APPLE WATCH. I HAVE SINUS NODE DYSFUNCTION WITH FIRST DEGREE BLOCK, WENKEBACH AND OTHER SINUS NODE ARRYTHMIAS. THE APPLE WATCH EKG(ELECTROCARDIOGRAM) APP FREQUENTLY REPORTS ATRIAL FIBRILLATION WHEN IN FACT IT IS A SINUS RELATED ARRYTHMIA WITH NO EVIDENCE OF A FIB. I WOULD ESTIMATE THE APP IS WRONG ABOUT 80-90% OF TIME. I PERSONALLY REVIEW ALL OF THE REPORTS AT THE TIME OF RECORDING. SINCE THE APP SAYS I HAVE AN A FIB DENSITY OF 25-30%, AND 80-90% ARE INCORRECT THIS IS NO MINOR PROBLEM. I SUSPECT THE APP IS SIMPLY LOOKING AT QRS INTERVALS TO MAKE ITS DETERMINATIONS. AS NOTED: SINUS NODE DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134078 APPLE WATCH ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA APPLE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other