BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL STS

    MDR report key: 23418386 · Received October 29, 2025

    Report

    Report Number
    2017865-2025-1003680
    Event Type
    Death
    Date Received
    October 29, 2025
    Report Date
    November 12, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502870
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 DUE TO INFECTION AND PATIENT DECEASED. AS RECEIVED, ONLY THE CONNECTOR PORTION WAS RETURNED IN ONE PIECE. ELECTRICAL TESTING DID NOT FIND ANY INDICATION OF CONDUCTOR FRACTURES OR INTERNAL SHORTS. VISUAL EXAMINATION DID NOT FIND ANY ANOMALIES WITH THE EXCEPTION OF PROCEDURAL DAMAGE.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003679. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003682. IT WAS REPORTED A PATIENT PRESENTED WITH SEPTIC SHOCK AND PASSED AWAY ON (B)(6) 2025. THEIR SYSTEM WAS REMOVED ON AN UNKNOWN DATE. IT WAS UNKNOWN WHETHER THE DEATH WAS RELATED TO ANY ABBOTT PRODUCT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210725 TENDRIL STS NO MATCH NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/46 P000159409 05414734502870

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Death