BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE MRI DR

    MDR report key: 21911327 · Received April 25, 2025

    Report

    Report Number
    2124215-2025-26474
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 15, 2025
    Report Date
    April 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559235
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER DEVICE EXHIBITED FARFIELD OVERSENSING. THE PATIENT WAS IN ATRIAL FIBRILLATION (AF) AND THESE AF SIGNALS WERE NOT CORRECTLY DETECTED; THEREFORE, REPROGRAMMING WAS PERFORMED. HOWEVER, THERE WERE AF SIGNALS WHICH WERE UNDERSENSED. THE PHYSICIAN STATED THAT THE PATIENT HAD AD WAS NOT PERMANENT AND IT WAS DUE TO THE AF MEDICATION. THIS PATIENT HAD INTRINSIC CONDUCTION. THERE WAS NO NOISE NOTED WITH PROVOCATIVE MANEUVERS. TECHNICAL SERVICES (TS) RECOMMENDED TO PERFORM X-RAY IMAGING TO ENSURE THAT THERE WAS NO RIGHT ATRIAL (RA) LEAD INTEGRITY ISSUE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390307 ACCOLADE MRI DR PACEMAKERS LWP BOSTON SCIENTIFIC CORPORATION L311 446634 00802526559235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown