BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES

    MDR report key: 17597600 · Received August 22, 2023

    Report

    Report Number
    2124215-2023-45230
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    July 6, 2023
    Report Date
    August 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS BRADY LEAD WAS HAVING PREMATURE ATRIAL CONTRACTION/COMPLEX (PAC). THE LEAD SENSITIVITY WAS PROGRAMMED TO 0.3 MILLI VOLTS FROM 0.45 MILLI VOLTS, PACED ATRIO-VENTRICULAR DELAY (PAV) TO 220, MODE WAS CHANGED TO DDIR, AND MITRAL VALVE PROLAPSE (MVP) WAS TURNED OFF. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306980 DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown