BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR ICD, US

    MDR report key: 23444221 · Received October 31, 2025

    Report

    Report Number
    2017865-2025-1003893
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    October 11, 2025
    Report Date
    January 20, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    UDI-DI
    05414734508094
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF INADEQUATE HV OUTPUT WERE NOT CONFIRMED. THE DEVICE VOLTAGE WAS AT NORMAL OPERATING LEVEL UPON RECEIPT. ANALYSIS OF DEVICE IMAGE WAS PERFORMED, AND NO ANOMALIES WERE NOTED. FURTHER ANALYSIS OF THE DEVICE¿S LEAD IMPEDANCE, LV OUTPUT AND HIGH VOLTAGE SHOCK TEST WERE FOUND TO BE NORMAL. LONGEVITY ASSESSMENT WAS PERFORMED, AND DEVICE WAS FOUND TO HAVE NORMAL BATTERY DEPLETION BASED ON USAGE.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003892. IT WAS REPORTED THAT PATIENT EXPERIENCED A VENTRICULAR TACHYCARDIA EPISODE ON (B)(6) 2025. FIVE SHOCKS WERE ATTEMPTED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE SHOCKS WERE ABANDONED DUE TO LOW DEFIBRILLATION IMPEDANCE ON THE RIGHT VENTRICULAR LEAD LEADING TO OVERCURRENT DETECTION. A 6TH SHOCK WAS DELIVERED SUCCESSFULLY BUT WAS INADEQUATE TO TERMINATE THE ARRHYTHMIA. THE ARRHYTHMIA ENDED UP SELF-TERMINATING 17 SECONDS AFTER THE LAST SHOCK. PATIENT WAS CLOSELY MONITORED IN A HOSPITAL AFTER THE EVENT. THE LEAD WAS CAPPED AND REPLACED ON 15 OCT 2025. THE ICD WAS ALSO EXPLANTED AND REPLACED DURING THE SAME PROCEDURE. PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905947 FORTIFY ASSURA DR ICD, US PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2357-40Q A000097605 05414734508094

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R 2088TC/46 LEAD