BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSERT-IQ¿ ICM

    MDR report key: 23296855 · Received October 15, 2025

    Report

    Report Number
    2017865-2025-1002694
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 28, 2025
    Report Date
    October 14, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    MXC
    UDI-DI
    05415067047816
    PMA / PMN Number
    K230286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1002693. IT WAS REPORTED A PATIENT'S PACEMAKER AND INSERTABLE CARDIAC MONITOR (ICM) PRESENTED WITH AN ELECTROGRAM (EGM) ANOMALY AND UNDER-SENSING. NO CHANGES WERE REPORTED. THE PATIENT STATUS WAS UNKNOWN, BUT THE PATIENT WAS INTUBATED AND SEDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288178 ASSERT-IQ¿ ICM Recorder, event, implantable cardiac, (without arrhythmia detection) MXC ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DM5300 S000090554 05415067047816

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male