BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEIR¿ LEADLESS PACEMAKER, RIGHT ATRIUM

    MDR report key: 23192259 · Received October 1, 2025

    Report

    Report Number
    2017865-2025-1001712
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 20, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    PNJ
    PMA / PMN Number
    P150035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE RETRACT REPORT MFR # 2017865-2025-1001712 AS IT WAS REPORTED THAT THE INABILITY TO IMPLANT THE LEAD WAS SOLELY ATTRIBUTED TO COMPLEXITIES POSED BY THE PATIENT'S ANATOMY. THERE WERE NO ALLEGATIONS OR COMPLAINTS MADE AGAINST THE LEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR LEADLESS PACEMAKER (LP) IMPLANT PROCEDURE. IT WAS NOTED THAT THE LP FAILED TO BE FIXED UPON MULTIPLE FIXATION ATTEMPTS. THE LP WAS NOT IMPLANTED DURING PROCEDURE ON (B)(6) 2025. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014598 AVEIR¿ LEADLESS PACEMAKER, RIGHT ATRIUM LEADLESS PACEMAKER PNJ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LSP201A S000106099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown