BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEFT BUNDLE BRANCH (LBB) LEAD

    MDR report key: 24115255 · Received January 20, 2026

    Report

    Report Number
    MW5182447
    Event Type
    Injury
    Date Received
    January 20, 2026
    Report Date
    November 20, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT BUNDLE BRANCH (LBB) LEAD HAD EXHIBITED INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LBB LEAD WAS NOT RETURNED FOR ANALYSIS. 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
    173748 LEFT BUNDLE BRANCH (LBB) LEAD DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 3830

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other