BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 22844296 · Received August 19, 2025

    Report

    Report Number
    2017865-2025-98059
    Event Type
    Death
    Date Received
    August 19, 2025
    Date of Event
    June 14, 2025
    Report Date
    September 25, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    UDI-DI
    05414734503341
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED IN HOSPITAL BETWEEN (B)(6) 2025 - (B)(6) 2025. THE PATIENT WAS SEEN FOR VASCULAR ISSUES IN CLINIC PRIOR TO ADMISSION. THE PATIENT PASSED AWAY (B)(6) 2025. THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DUE TO THE DEVICE/SYSTEM. FURTHER INFORMATION WAS REQUESTED FROM THE CLINICIAN BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252388 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR PERMANENT DEFIBRILLATOR ELECTRODES NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7122Q/65 A000079471 05414734503341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death| H