BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV LEAD

    MDR report key: 19479470 · Received June 5, 2024

    Report

    Report Number
    MW5155834
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Report Date
    April 1, 2024
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RV (RIGHT VENTRICULAR) LEAD IMPEDANCE ISSUE. 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
    10027 RV LEAD PERMANENT DEFIBRILLATOR ELECTRODES NVY BIOTRONIK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown