BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 19146891 · Received April 19, 2024

    Report

    Report Number
    2124215-2024-24023
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    March 10, 2024
    Report Date
    April 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE DEPLETING PREMATURELY. WITHIN ONE YEAR, THE ESTIMATED LONGEVITY DECREASED FROM TWO YEARS TO SIX MONTHS. WHILE REPLACEMENT AND RETURN ARE EXPECTED, THIS PACEMAKER REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695814 INGENIO IMPLANTABLE PACEMAKER LWW BOSTON SCIENTIFIC CORPORATION J172 104629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown