BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    MDR report key: 24331676 · Received February 12, 2026

    Report

    Report Number
    MW5183743
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Report Date
    December 8, 2025
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025 15:00:06. LV TIP TO LV (LEFT VENTRICULAR) RING LEAD IMPEDANCE >3000 OHMS. ON (B)(6) 2025 15:00:06. RV (RIGHT VENTRICULAR) DEFIBRILLATOR LEAD IMPEDANCE >200 OHMS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). HEALTH EFFECT CODE: 4582. DEVICE PROBLEM CODE: 2950. REFERENCE REPORT: MW5183744.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390523 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN BIOTRONIK SE & CO. KG 350 SERTOX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown