BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 19320953 · Received May 14, 2024

    Report

    Report Number
    MW5154886
    Event Type
    Other
    Date Received
    May 14, 2024
    Report Date
    March 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    POSSIBLE CAPTURE ISSUE NOTED ON RIGHT VENTRICULAR LEAD ON CURRENT EGM(ELECTROGRAM). RV(RIGHT VENTRICULAR) THRESHOLD IS LISTED AS HIGH. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF REPORT: MW5154885.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475105 PERMANENT DEFIBRILLATOR ELECTRODES IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CR NVY BOSTON SCIENTIFIC CORP. 0049

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown