BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9758/58

    MDR report key: 24062923 · Received January 13, 2026

    Report

    Report Number
    3009660953-2026-00001
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    November 6, 2025
    Report Date
    January 13, 2026
    Manufacturer
    SORIN CRM SAS
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PER MEDWATCH NOTICE MW5180378: "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
    114513 9758/58 RV LEAD NVN SORIN CRM SAS 9758/58

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other