BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL MRI

    MDR report key: 23417982 · Received October 29, 2025

    Report

    Report Number
    2017865-2025-1003672
    Event Type
    Death
    Date Received
    October 29, 2025
    Report Date
    December 4, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734504638
    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

    AS RECEIVED, ONLY THE CONNECTOR PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS. ELECTRICAL TESTING THAT COULD BE MEASURED DID NOT FIND ANY INDICATION OF CONDUCTOR FRACTURES OR INTERNAL SHORTS. VISUAL INSPECTION OF THE LEAD DID NOT FIND ANY ANOMALIES WITH THE EXCEPTION OF PROCEDURAL DAMAGE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND REVIEW OF THE STERILIZATION RECORDS CONFIRMED NORMAL STERILIZATION CYCLES FOR THE PRODUCTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES. THE CAUSE OF INFECTION COULD NOT BE TRACED TO THE DEVICE.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003669. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003673. 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
    219511 TENDRIL MRI NO MATCH NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LPA1200M/58 S000034903 05414734504638

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Death