BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVEIR¿ DELIVERY CATHETER

    MDR report key: 22905011 · Received August 27, 2025

    Report

    Report Number
    2017865-2025-98757
    Event Type
    Death
    Date Received
    August 27, 2025
    Date of Event
    August 8, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    PNJ
    PMA / PMN Number
    P150035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR LEADLESS PACEMAKER (LP) IMPLANT PROCEDURE. DURING THE PROCEDURE, THE LP EXHIBITED AN LARGE INCREASE IN PACING IMPEDANCE UPON FIXATION. IT WAS NOTED THAT DURING REPOSITIONING, THE CATHETER SLIPPED FORWARD, TRAVELING BEYOND THE DEVICE. CARDIAC PERFORATION WAS NOTED AFTER INJECTION OF CONTRAST. ECHOCARDIOGRAM CONFIRMED PERCIARDIAL EFFUSION. DURING TRANSPORT, THE PATIENT DEVELOPED CARDIAC TAMPONADE AND DUE TO MEDICAL DIRECTIVE OF DNR/DNI, THE PATIENT HAD DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250764 AVEIR¿ DELIVERY CATHETER LEADLESS PACEMAKER PNJ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LSCD201

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Death