BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 24278943 · Received February 5, 2026

    Report

    Report Number
    MW5183467
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Report Date
    November 6, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FRACTURE POSSIBLE FRACTURE INSULATION DAMAGE LIA WAS TRIPPED DUE TO SUDDEN INCREASE IN SIC COUNT AND DETECTION OF NOISE ON THE RV LEAD VIA EGM STORAGE. (B)(6) 2016 21:00:14 LVTIP TO RVCOIL LEAD IMPEDANCE 190 OHMS. 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
    335973 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB ABBOTT MEDICAL 1084T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown