BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL MRI

    MDR report key: 23417984 · Received October 29, 2025

    Report

    Report Number
    2017865-2025-1003673
    Event Type
    Death
    Date Received
    October 29, 2025
    Report Date
    October 29, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734504621
    PMA / PMN Number
    P140033
    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 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: 2017865-2025-1003669. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003672. IT WAS REPORTED A PATIENT PRESENTED WITH SEVERE SEPSIS AND PASSED AWAY ON (B)(6) 2025. THEIR SYSTEM WAS EXPLANTED ON AN UNKNOWN DATE. IT WAS UNKNOWN WHETHER THE DEVICE OR DEVICE RELATED PROCEDURE CAUSED THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215439 TENDRIL MRI No Match NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LPA1200M/52 A000044392 05414734504621

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Death