BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC DEVICE:L331 ACCOLADE MRI EL/758439 PACEMAKER

    MDR report key: 23125366 · Received September 22, 2025

    Report

    Report Number
    MW5176426
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    September 19, 2025
    Report Date
    September 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC DEVICE: L331 ACCOLADE MRI EL/(B)(6) BATTERY STATUS: VOLTAGE WAS TOO LOW FOR PROJECTED REMAINING CAPACITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206368 BOSTON SCIENTIFIC DEVICE:L331 ACCOLADE MRI EL/758439 PACEMAKER IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L331

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| O