BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BKC LEAD

    MDR report key: 24290328 · Received February 9, 2026

    Report

    Report Number
    MW5183492
    Event Type
    Injury
    Date Received
    February 9, 2026
    Report Date
    December 8, 2025
    Manufacturer
    BIOTRONIK SE & CO. KG.
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE BKC LEAD WAS REMOVED AND REPLACED BY A LEADLESS IPG DUE TO EROSION. DISCLAIMER STATEMENT: 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
    352116 BKC LEAD PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ BIOTRONIK SE & CO. KG. 394969

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown