BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 23241473 · Received October 8, 2025

    Report

    Report Number
    2017865-2025-1002191
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 24, 2025
    Report Date
    November 19, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF FAILURE TO CAPTURE WAS CONFIRMED. AS RECEIVED, A COMPLETE LEAD WAS RETURNED IN TWO PIECES. VISUAL EXAMINATION NOTED AN EXTERNAL INSULATION ABRASION BREACHING THE OUTER INSULATION AND EXPOSING THE OUTER COIL AT THE PROXIMAL REGION. THE CAUSE OF THE REPORTED EVENT WAS DUE TO THE EXPOSURE OF THE OUTER COIL IN THE ABRASION REGION CONSISTENT WITH FRICTION TO DEVICE CAN.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1002189. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1002190. IT WAS REPORTED THAT A BRADYCARDIC PATIENT PRESENTED TO THE EMERGENCY ROOM WITH BOTH THEIR RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS FAILING TO CAPTURE. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PACEMAKER WAS SUBJECT TO THE ASSURITY AND ENDURITY PACEMAKERS HEADER ANOMALY ADVISORY ISSUED BY ABBOTT ON 15 MARCH 2021. THE PACEMAKER AND BOTH LEADS WERE EXPLANTED AND REPLACED. PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513020 TENDRIL STS NO MATCH NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/58 S000070811

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention