BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 23444287 · Received October 31, 2025

    Report

    Report Number
    2017865-2025-1003892
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    October 11, 2025
    Report Date
    October 31, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003893. 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 (B)(6) 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
    2196144 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR Permanent defibrillator electrodes NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7120Q/52 2895293

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention| H 2088TC/46 LEAD.