BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEIR¿ DELIVERY CATHETER

    MDR report key: 23192543 · Received October 1, 2025

    Report

    Report Number
    2017865-2025-1001715
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 2, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    PNJ
    PMA / PMN Number
    P150035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1001381. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1001389. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1001390. IT WAS REPORTED THAT PATIENT EXPERIENCED LOW BLOOD PRESSURE THE DAY AFTER ON (B)(6) 2025) A LEADLESS PACEMAKER (LP) SYSTEM IMPLANT PROCEDURE ON (B)(6) 2025). AN ULTRASOUND REVEALED PATIENT HAD SUSTAINED A PERICARDIAL EFFUSION IN THE RIGHT ATRIAL APPENDAGE. IT WAS SUSPECTED TO HAVE OCCURRED DURING THE RIGHT VENTRICULAR (RV) PORTION OF THE PROCEDURE. THE EFFUSION WAS DRAINED SUCCESSFULLY WITH A PERICARDIAL TAP. TAP WAS REMOVED THE FOLLOWING DAY ON (B)(6) 2025) AND PATIENT WAS STABLE.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED NOTED PHYSICIAN WAS UNABLE TO FIND A SUITABLE POSITION FOR THE IMPLANT OF THE RIGHT ATRIAL LEADLESS PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015644 AVEIR¿ DELIVERY CATHETER LEADLESS PACEMAKER PNJ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LSCD201 10811475

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention