BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR ICD, US

    MDR report key: 20076963 · Received August 27, 2024

    Report

    Report Number
    2017865-2024-63280
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 26, 2024
    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
    PA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF BACKUP OPERATION WAS CONFIRMED. ANALYSIS OF DEVICE IMAGE FOUND THE DEVICE WENT INTO BACKUP MODE DUE TO A POWER-ON-RESET (POR) AS A RESULT OF DELIVERING AN EXCESSIVE NUMBER OF BACK-TO-BACK HIGH VOLTAGE (HV) THERAPIES WITHIN A SHORT TIMEFRAME WHICH DROPPED THE BATTERY BELOW END-OF-SERVICE (EOS) LEVEL. THE EXTENDED CHARGE TIME EVENT TOOK PLACE WHILE THE DEVICE¿S BATTERY LEVEL HAD BEEN DROPPED BELOW EOS VOLTAGE. INTERROGATION OF THE DEVICE REVEALED THE DEVICE WAS AT EOS WHEN RECEIVED. A LONGEVITY CALCULATION WAS PERFORMED AND FOUND THE BATTERY DEPLETION WAS NORMAL BASED ON THE DEVICE USAGE. FUNCTIONAL TESTING WAS NORMAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IN-CLINIC FOLLOW-UP EXPERIENCING ARRHYTHMIA. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN BACK-UP MODE. THE PATIENT THEN PRESENTED IN THE EMERGENCY ROOM. THE ICD WAS REPROGRAMMED AND RESTORED. IT WAS THEN NOTED THAT THE ICD FAILED TO CHARGE WHILE TRYING TO RUN A CAPACITOR MAINTENANCE. THE ICD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29117 FORTIFY ASSURA DR ICD, US PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2357-40Q A000044280 05414734508094

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention| H DURATA| TENDRIL