BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVEIR¿ LEADLESS PACEMAKER, RIGHT ATRIUM

    MDR report key: 23457898 · Received November 3, 2025

    Report

    Report Number
    2017865-2025-1003983
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    October 7, 2025
    Report Date
    December 19, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    PNJ
    UDI-DI
    05415067040701
    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

    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. REPORTED EVENT OF CAPTURING PROBLEM WAS NOT CONFIRMED. VISUAL INSPECTION OF THE DEVICE FOUND NO ANOMALY ON OUTER AND INNER HELIX, HELIX LENGTHS WERE WITHIN SPECIFICATION. FURTHER ANALYSIS PERFORMED FOUND NO ANOMALIES CONTRIBUTING TO REPORTED EVENT OF CAPTURING PROBLEM.

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON REVIEW, THE LEADLESS PACEMAKER SHOULD NOT HAVE BEEN SUBMITTED UNDER 2017865-2025-1003984 AS A MEDICAL DEVICE REPORT (MDR) AS THE EVENT DID NOT INDICATE A MALFUNCTION CAUSED A SERIOUS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED PREMATURE BATTERY DEPLETION WAS NOT ALLEGED ON THE RA LP. BOTH THE RA LP AND RV LP WERE REPLACED WITH A BIVENTRICULAR PACEMAKER SYSTEM. THE PATIENT WAS ASYMPTOMATIC AND STABLE THROUGHOUT THE PROCEDURE. FURTHERMORE, THERE WAS NO ALLEGED MALFUNCTION ON THE RV LP. IT WAS EXPLANTED DUE TO THE PATIENT REQUIRING CARDIAC RESYNCHRONIZATION THERAPY (CRT).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL LEADLESS PACEMAKER (RA LP) WAS EXPLANTED ON (B)(6) 2025 WITH A NOTE STATING ATRIAL THRESHOLD WAS AT '5.5 @ 1.5'. ADDITIONALLY, THE REMAINING LONGEVITY OF THE RA LP WAS 5 MONTHS DESPITE HAVING BEEN IMPLANTED IN (B)(6) 2025, INDICATING THERE WAS RAPID BATTERY LOSS EXHIBITED BY THE RA LP. THE RIGHT VENTRICULAR LEADLESS PACEMAKER (RV LP) WAS EXPLANTED ON (B)(6) 2025 AS WELL WITH A CLAIM THAT IT REACHED ERI, HOWEVER, IT WAS ONLY IMPLANTED IN (B)(6) 2025, AND THE REMAINING LONGEVITY WAS 15.3 YEARS. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480324 AVEIR¿ LEADLESS PACEMAKER, RIGHT ATRIUM LEADLESS PACEMAKER PNJ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LSP201A S000102178 05415067040701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention