BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV LEAD

    MDR report key: 23583393 · Received November 18, 2025

    Report

    Report Number
    MW5178984
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    December 9, 2021
    Report Date
    October 1, 2025
    Manufacturer
    ELA / SORIN CRM SAS
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    APPEARS TO BE POSSIBLE RIGHT VENTRICULAR UNDER-SENSING CAUSING INAPPROPRIATE VENTRICULAR PACING ON CURRENT EGM. RV BIPOLAR LEAD IMPEDANCE WARNING ON (B)(6) 2021. CURRENTLY MEASURING 38 OHMS. RV UNIPOLAR 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
    1768355 RV LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN ELA / SORIN CRM SAS ELAPASSP752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown