BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV LEAD

    MDR report key: 17534434 · Received August 12, 2023

    Report

    Report Number
    MW5141335
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    July 22, 2016
    Report Date
    October 18, 2021
    Manufacturer
    UNKNOWN
    Product Code
    NVY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2016 15:00:32 RV BIPOLAR LEAD IMPEDANCE >3000 OHMS. 3000 OHMS (B)(6) 2016 15:00:32 RVTIP TO RVCOIL LEAD IMPEDANCE >3000 OHMS. 3000 OHMS (B)(6) 2016 15:00:32 RV DEFLB LEAD IMPEDANCE >200 OHMS. 200 OHMS (B)(6) 2016 14:58:47 RV BIPOLAR LEAD IMPEDANCE >3000 OHMS. 3000 OHMS (B)(6) 2016 14:58:47 RV TIP TO RVCOIL LEAD IMPEDANCE >3000 OHMS. 3000 OHMS (B)(6) 2016 14:58:47 RV DEFIB LEAD IMPEDANCE > 200 OHMS. 200 OHMS. (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
    1084806 RV LEAD PERMANENT DEFIBRILLATOR ELECTRODES NVY UNKNOWN 7122Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown