BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASSURITY MRI

    MDR report key: 23418383 · Received October 29, 2025

    Report

    Report Number
    2017865-2025-1003679
    Event Type
    Death
    Date Received
    October 29, 2025
    Report Date
    October 29, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    UDI-DI
    05414734509589
    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. ANALYSIS FOUND INTERROGATION RESULTS WERE NORMAL AND THERE WAS AN ACCEPTABLE VISUAL SCREEN.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003680. 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
    210722 ASSURITY MRI Implantable pulse generator, pacemaker (non-CRT) LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2272 A000139606 05414734509589

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Death