BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE MRI SR

    MDR report key: 24880944 · Received April 15, 2026

    Report

    Report Number
    2124215-2026-20275
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 17, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559211
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT INVESTIGATION IS CURRENTLY UNDERWAY. A SUPPLEMENTAL FINAL REPORT WILL BE FILED UPON INVESTIGATION COMPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER EXHIBITED SIGNS OF PREMATURE BATTERY DEPLETION WITH BATTERY LONGEVITY DECREASING FROM FIVE YEARS TO 2.5 YEARS WITHIN ONE YEAR. ADDITIONALLY, LOWER RATE LIMIT (LRL) OF THE PACEMAKER WAS AT 60 AND NOW AT 80. TECHNICAL SERVICES (TS) REVIEWED THE DATA AND SUSPECTED THE INCREASE IN LRL TO BE THE CAUSE OF DECREASE IN LONGEVITY. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308146 ACCOLADE MRI SR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L310 803872 00802526559211

    Patients

    Seq Age Sex Outcome Treatment
    1