BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSERT-IQ¿ ICM

    MDR report key: 23231156 · Received October 7, 2025

    Report

    Report Number
    2017865-2025-1002116
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 22, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    MXC
    PMA / PMN Number
    K230286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CORRECT COMPONENT CODE IN H6 SHOULD HAVE BEEN "4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE", RATHER THAN " 3079 - PATIENT LEAD".

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON REVIEW THE INSERTABLE CARDIAC MONITOR (ICM), MANUFACTURER REPORT 2017865-2025-1002116, SHOULD NOT HAVE BEEN SUBMITTED AS A MEDICAL DEVICE REPORT (MDR) AS THERE WAS NO ALLEGATION OF MALFUNCTION ON THE ICM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. TRANSMISSIONS SHOWED THAT THE INSERTABLE CARDIAC MONITOR (ICM) HAD EXHIBITED UNDER-SENSING, WHICH RESULTED IN A PAUSE TRANSMISSION FOLLOWING AN ABLATION PROCEDURE. NO INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867678 ASSERT-IQ¿ ICM RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION) MXC ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DM5500 S000101467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown