BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 17481031 · Received August 8, 2023

    Report

    Report Number
    MW5120734
    Event Type
    Other
    Date Received
    August 8, 2023
    Date of Event
    January 19, 2021
    Report Date
    August 1, 2023
    Manufacturer
    ST. JUDE/ABBOTT MEDICAL
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RV (RIGHT VENTRICULAR) BIPOLAR LEAD IMPEDANCE WARNING ON (B)(6) 2021. 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
    2100187 PERMANENT DEFIBRILLATOR ELECTRODES PERMANENT DEFIBRILLATOR ELECTRODES NVY ST. JUDE/ABBOTT MEDICAL 7022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown