BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE MRI DR

    MDR report key: 12713605 · Received October 28, 2021

    Report

    Report Number
    2124215-2021-29960
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    August 22, 2021
    Report Date
    October 28, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL WITH DIZZINESS, BRADYCARDIA, AND SECOND DEGREE HEART BLOCK (HB). A TEMPORARY PACEMAKER WAS USED. IN THE POSTOPERATIVE RECOVERY AREA, THERE WERE ABNORMAL ELECTRICAL SIGNALS NOTED ON BOTH THE ATRIAL AND VENTRICULAR CHANNELS OF THE PERMANENT PACEMAKER. PACING INHIBITION AND RECURRENT BRADYCARDIA WERE OBSERVED. SUBSEQUENTLY, THE OLD DEVICE WAS REPLACED, BUT THE LEADS REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609541 ACCOLADE MRI DR IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC CORPORATION L311

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R