BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFT BUNDLE BRANCH (LBB) LEAD

    MDR report key: 21816868 · Received April 10, 2025

    Report

    Report Number
    MW5168842
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Report Date
    March 17, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    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 THIS LEFT BUNDLE BRANCH (LBB) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AS A RESULT IT WAS EXPLANTED AND REPLACED. NO 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
    1092747 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