BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE MRI DR

    MDR report key: 11263501 · Received February 1, 2021

    Report

    Report Number
    2124215-2021-02541
    Event Type
    Injury
    Date Received
    February 1, 2021
    Date of Event
    December 23, 2020
    Report Date
    February 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559228
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT RECENTLY EXPERIENCED AN EPISODE OF SYNCOPE AND THEY FELL DOWN. THEY NOTED THAT THEY ALSO EXPERIENCED SYNCOPE BEFORE HAVING A PACEMAKER SYSTEM BUT SINCE HAVING THE PACEMAKER SYSTEM, THEY HAVE HAD ATRIAL FIBRILLATION AND IRREGULAR HEART RATES. THE PATIENT ALSO NOTED THAT ONE OF THE LEADS IS NOT WORKING. THE PATIENT DID NOT ELABORATE AND DID NOT HAVE ANY ADDITIONAL INFORMATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO THEIR PHYSICIAN. THE PATIENTS FOLLOWING HEALTHCARE FACILITY (HCF) WAS SUBSEQUENTLY CONTACTED AND THEY WERE NOT AWARE OF THE PATIENTS REPORTED SYMPTOMS OR ANY LEAD ISSUES. THEY INDICATED THAT THE PATIENT HAS NOT BEEN SEEN IN THE OFFICE AND THE PATIENT HAS DISCONNECTED THEIR REMOTE MONITORING COMMUNICATOR SO THE HCF HAS NOT RECEIVED ANY ALERTS OR COMMUNICATION. THE HCF RECENTLY CONTACTED THE PATIENT TO SCHEDULE AN OFFICE VISIT TO PERFORM A PACEMAKER DEVICE CHECK AND THE PATIENT STATED THAT THEY ARE LOOKING FOR ANOTHER CARDIOLOGIST CLOSER TO HOME. THE CAUSE OF THE PATIENTS SYMPTOMS IS UNKNOWN. THE PRODUCTS REMAIN IN-SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159430 ACCOLADE MRI DR IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC CORPORATION L311 400709 00802526559228

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other