BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 23416558 · Received October 29, 2025

    Report

    Report Number
    2017865-2025-1003637
    Event Type
    Injury
    Date Received
    October 29, 2025
    Report Date
    October 29, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734501989
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003638. IT WAS REPORTED THE PATIENT'S ATRIAL LEAD AND LEFT VENTRICULAR LEAD PRESENTED WITH NON-CAPTURE. BOTH LEADS WERE EXPLANTED IN A PROCEDURE ON (B)(6) 2025. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701551 TENDRIL SDX LEAD No Match NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1688TC/46 0002109797 05414734501989

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).| RIGHT VENTRICULAR (RV) LEAD.