BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, U1.6 SJ4 US

    MDR report key: 23444339 · Received October 31, 2025

    Report

    Report Number
    2017865-2025-1003902
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    June 20, 2025
    Report Date
    January 7, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED COMPLAINT OF INAPPROPRIATE SHOCK WAS NOT CONFIRMED. THE DEVICE WAS RECEIVED IN NORMAL END-OF-SERVICE (EOS) RANGE OF OPERATION. ANALYSIS OF DEVICE IMAGE WAS PERFORMED, AND NO ANOMALIES WERE NOTED. FURTHER ELECTRICAL TESTING WAS PERFORMED, INCLUDING HIGH VOLTAGE SHOCK TEST, AND NO ISSUES WERE NOTED. LONGEVITY ASSESSMENT FOUND THE DEVICE WAS OPERATING AT THE END-OF-SERVICE (EOS) VOLTAGE CONSISTENT WITH NORMAL USAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND RIGHT VENTRICULAR (RV) LEAD WAS CAPPED DUE TO INAPPROPRIATE SHOCK. THE PATIENT'S STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588169 FORTIFY VR, U1.6 SJ4 US PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD1231-40Q 3427591

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| O