BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEIR¿ DELIVERY CATHETER

    MDR report key: 23343547 · Received October 20, 2025

    Report

    Report Number
    2017865-2025-1003013
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    October 3, 2025
    Report Date
    April 24, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    PNJ
    UDI-DI
    05415067038487
    PMA / PMN Number
    P150035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H11 - 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.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1003012. IT WAS REPORTED THAT PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE AFTER TWO ATRIAL LEADLESS PACEMAKER REDOCKING ATTEMPTS WITH A DELIVERY CATHETER. AN ECHOCARDIOGRAPHY WAS PERFORMED AND CONFIRMED PERICARDIAL EFFUSION. DRAINAGE WAS PERFORMED BUT PATIENT'S VITALS WERE STILL UNSTABLE. A CARDIAC TAMPONADE WAS SUSPECTED, SO AN EMERGENCY THORACOTOMY WAS PERFORMED. TWO PERFORATIONS WERE FOUND AND LIGATED IN THE RIGHT ATRIAL APPENDAGE. PATIENT'S VITALS STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319951 AVEIR¿ DELIVERY CATHETER LEADLESS PACEMAKER PNJ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LSCD201 10989914 05415067038487

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention