BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSERT-IQ¿ ICM

    MDR report key: 22832852 · Received August 18, 2025

    Report

    Report Number
    2017865-2025-97952
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    July 31, 2025
    Report Date
    September 26, 2025
    Manufacturer
    ABBOTT
    Product Code
    MXC
    UDI-DI
    05415067047793
    PMA / PMN Number
    K230286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A MISSING EGM FOR THE ATRIAL FIBRILLATION (AF) EPISODE ON (B)(6) 2025 WAS CONFIRMED. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE EGM MEMORY WAS FULL OF HIGHER PRIORITY EGMS. THE AF EGM WAS MISSING DUE TO A MORE RECENT AF EGM OVERWRITING IT.; HOWEVER, THE RECENT EGM ULTIMATELY DID NOT MEET THE MINIMUM DURATION AND WAS DELETED ALONG WITH THE CORRESPONDING AF EPISODE LOG INFORMATION. THE FIRMWARE IS BEHAVING PER EGM PRIORITIZATION DESIGN.

    Description of Event or Problem · 0

    DURING A REMOTE FOLLOW-UP, MISSING EGMS WERE OBSERVED FROM THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED, BUT NO INTERVENTION HAS BEEN 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
    2133596 ASSERT-IQ¿ ICM RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION) MXC ABBOTT DM5000 S000103725 05415067047793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown