BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANT EL ICD DR

    MDR report key: 21527787 · Received March 5, 2025

    Report

    Report Number
    2124215-2025-13663
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 20, 2025
    Report Date
    March 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526587801
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED FOR REVIEW OF AN ELECTROGRAM (EGM) FOR THIS PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM AS THERE WAS A CONCERN OF RIGHT ATRIAL (RA) LOSS OF CAPTURE. IT WAS NOTED THAT THE PATIENT ALSO HAS A CCM IMPULSE DEVICE. TECHNICAL SERVICES (TS) REVIEWED THE DATA AND FOUND THERE IS INTERMITTENT ATRIAL UNDERSENSING OF P WAVES. AS A RESULT, THERE IS FUNCTIONAL NON-CAPTURE OF THE AP WHICH OCCURS DURING REPOLARIZATION. ADDITIONALLY, THERE WAS SEVERAL AP-NS MARKERS. TS RECOMMENDED AN IN-CLINIC EVALUATION AND PROVIDED PROGRAMMING OPTIONS. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473366 VIGILANT EL ICD DR IMPLANTABLE DEVICE LWS BOSTON SCIENTIFIC CORPORATION D233 619341 00802526587801

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male