BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 24444228 · Received February 25, 2026

    Report

    Report Number
    2124215-2026-10440
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    December 22, 2025
    Report Date
    February 25, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    UDI-DI
    00802526525544
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS SUSPECTED OF EXHIBITING PREMATURE BATTERY DEPLETION. THIS DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THIS DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510133 INGENIO IMPLANTABLE CARDIAC DEVICE LWW BOSTON SCIENTIFIC CORPORATION J172 293690 00802526525544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H