BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RV LEAD

    MDR report key: 23781017 · Received December 11, 2025

    Report

    Report Number
    MW5180378
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 6, 2025
    Report Date
    December 8, 2025
    Manufacturer
    ELA MEDICAL / SORIN CRM SAS
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS LETTER IS TO INFORM YOU OF RECEIPT OF INFORMATION ABOUT AN ADVERSE EVENT REGARDING A PRODUCT WHICH (B)(6) DID NOT MANUFACTURE OR IMPORT. IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INSULATION ANOMALY. THE LEAD WAS CAPPED AND REPLACED. 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
    2780362 RV LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN ELA MEDICAL / SORIN CRM SAS 9758/58

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown