BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE MRI EL DR

    MDR report key: 21480086 · Received February 27, 2025

    Report

    Report Number
    2124215-2025-12163
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    February 20, 2025
    Report Date
    February 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO HAVE THE RIGHT ATRIAL AUTOMATIC THRESHOLD (RAAT) TEST IN PROGRAMMED AMPLITUDE OR SUSPENDED. UPON FURTHER REVIEW OF THE STORED RIGHT ATRIAL (RA) ELECTROGRAM (EGM), ATRIAL UNDERSENSING WAS OBSERVED RESULTING IN LOSS OF CAPTURE (LOC) IN THE SUBSEQUENT ATRIAL PACE. TECHNICAL SERVICES (TS) RECOMMENDED REPROGRAMMING OPTIONS SUCH AS INCREASING THE ATRIAL SENSITIVITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286113 ACCOLADE MRI EL DR PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION L331 631742

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Unknown