BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSERT-IQ¿ ICM

    MDR report key: 20614392 · Received November 5, 2024

    Report

    Report Number
    2017865-2024-69104
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 29, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    MXC
    UDI-DI
    05415067047809
    PMA / PMN Number
    K230286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF AN INABILITY TO PAIR AND AN INABILITY TO INTERROGATE THE DEVICE IN CLINIC WITH A MERLIN PROGRAMMER WAS CONFIRMED. THE SESSION RECORD, DEVICE IMAGE, AND PATIENT APPLICATION LOGS WERE REVIEWED AND MULTIPLE ERRORS WERE OBSERVED RELATED TO THE HUMMINGBIRD CHIP, WHICH CAUSED THE TELEMETRY ANOMALY. AN INVESTIGATION WAS OPENED WITH THE VENDOR OF THE CHIP, BUT NO ROOT CAUSE WAS ABLE TO BE DETERMINED. THE REPORTED EVENT OF FAILURE TO INTERROGATE WAS CONFIRMED. THE DEVICE WAS RECEIVED WITHOUT BLE TELEMETRY AND COULD NOT BE INTERROGATED. TO ENABLE FURTHER TESTING, THE DEVICE WAS CUT OPEN, AND TELEMETRY WAS REGAINED. THE PRODUCT CODE WAS RELOADED TO RECOVER THE DEVICE FROM RESET MODE. ADDITIONAL INVESTIGATION BY THE SOFTWARE TEAM CONFIRMED THAT THE TELEMETRY ANOMALY WAS ASSOCIATED WITH AN INTEGRATED CIRCUIT, WHICH LED TO THE REPORTED COMPLAINT. A LONGEVITY ASSESSMENT WAS PERFORMED, AND THE DEVICE WAS FOUND TO BE OPERATING WITHIN THE NORMAL RANGE, WITH APPROPRIATE REMAINING LONGEVITY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION NOTED THAT THE INSERTABLE CARDIAC MONITOR WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S INSERTABLE CARDIAC MONITOR EXHIBITED LOSS OF BLUETOOTH TELEMETRY. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429884 ASSERT-IQ¿ ICM RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION) MXC ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DM5500 S000093979 05415067047809

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention