BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEFT BUNDLE BRANCH (LBB) LEAD

    MDR report key: 22178721 · Received June 10, 2025

    Report

    Report Number
    MW5171247
    Event Type
    Injury
    Date Received
    June 10, 2025
    Report Date
    May 27, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    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 LEFT BUNDLE BRANCH (LBB) LEAD WAS EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. 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
    2033633 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