BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 17534419 · Received August 12, 2023

    Report

    Report Number
    MW5141320
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    August 1, 2022
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    NHI GRAND ISLAND TACHY (B)(6). (B)(6). CALLER NOTED THAT AT THE 3 MONTH CHECK IN "(B)(6) OF 2021" THEY NOTED TWOS POST V PACE AND THEY ARE STILL SEEING IT IN MORE RECENT CARELINK TXS. NO PATIENT SYMPTOMS OR COMPLAINTS. THEY JUST CAPTURED IT IN CARELINK. SEE CARELINK REPORT (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050719 PERMANENT DEFIBRILLATOR ELECTRODES PERMANENT DEFIBRILLATOR ELECTRODES NVY BOSTON SCIENTIFIC 673

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown