BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

    MDR report key: 23158629 · Received September 26, 2025

    Report

    Report Number
    2017865-2025-1001389
    Event Type
    Injury
    Date Received
    September 26, 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5 - ADDITIONAL RELATED MANUFACTURER REFERENCE NUMBER.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2025-1001381 AND 2017865-2025-1001390. IT WAS REPORTED THAT PATIENT EXPERIENCED LOW BLOOD PRESSURE THE DAY AFTER (9 SEP 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.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-1001381, 2017865-2025-1001390, AND 2017865-2025-1001715. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317021 AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE LEADLESS PACEMAKER PNJ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LSP112V S000103844

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention