BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOT DX¿ ICM

    MDR report key: 20772555 · Received November 25, 2024

    Report

    Report Number
    2017865-2024-70851
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    November 11, 2024
    Report Date
    January 22, 2025
    Manufacturer
    ABBOTT
    Product Code
    MXC
    UDI-DI
    05415067040046
    PMA / PMN Number
    K163407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF FALSE AF EPISODES WAS CONFIRMED. THESE FALSE AF EPISODES WERE TRIGGERED DUE TO FREQUENT PACS AND ALGORITHM LIMITATION IN JOT DX. NO DEVICE MALFUNCTION WAS FOUND.

    Description of Event or Problem · 0

    DURING REMOTE MONITORING, A DIAGNOSTIC ANOMALY OCCURRED IN WHICH THE DEVICE INCORRECTLY LABELED EVENTS AS ATRIAL FIBRILLATION. NO INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    DURING REMOTE MONITORING, EPISODES OF OVERSENSING WERE OBSERVED ON THE DEVICE. NO INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828973 JOT DX¿ ICM RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION) MXC ABBOTT DM4500 P000174349 05415067040046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown