BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 22645740 · Received July 29, 2025

    Report

    Report Number
    2124215-2025-51325
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 16, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526543425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2025 - AMENDMENT: PROPHYLACTIC REPLACEMENT. THERE ARE NO ALLEGATIONS OR CONCERNS AGAINST THIS LEAD AND THERE IS NO EVIDENCE OF MALFUNCTION. THEREFORE, THIS EVENT DOES NOT MEET COMPLAINT CRITERIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS. SUPPLEMENTAL REPORT WILL BE SENT WITH CLARIFICATION. CGJ.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE OPERATING IN SAFETY MODE. THE PACEMAKER REPLACEMENT WAS RECOMMENDED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE OPERATING IN SAFETY MODE. THE PACEMAKER REPLACEMENT WAS RECOMMENDED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788937 INGENIO PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION J177 104039 00802526543425

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female