BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL STS

    MDR report key: 23381281 · Received October 24, 2025

    Report

    Report Number
    2017865-2025-1003357
    Event Type
    Death
    Date Received
    October 24, 2025
    Date of Event
    August 22, 2025
    Report Date
    October 30, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502894
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES. THE LEAD WAS RETURNED DUE TO INFECTION AND PATIENT DECEASED. AS RECEIVED, ONLY THE CONNECTOR PORTION OF THE LEAD WAS RETURNED IN ONE PIECE. VISUAL EXAMINATION OF THE LEAD DID NOT FIND ANY ANOMALIES EXCEPT FOR PROCEDURAL DAMAGE. ELECTRICAL TESTING OF THE LEAD DID NOT FIND ANY INDICATION OF CONDUCTOR FRACTURES OR INTERNAL SHORTS.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003353. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003355. IT WAS REPORTED A PATIENT PRESENTED WITH RESPIRATORY FAILURE, SEPSIS, AND AN INFECTED HEMATOMA AND PASSED. THE SYSTEM WAS EXPLANTED IN A PROCEDURE ON (B)(6) 2025. IT WAS NOT STATED WHETHER THE DEATH WAS RELATED TO ANY ABBOTT DEVICE OR DEVICE RELATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703396 TENDRIL STS NO MATCH NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/58 A000097708 05414734502894

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Death