BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 24198551 · Received January 27, 2026

    Report

    Report Number
    MW5182902
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Report Date
    November 6, 2025
    Manufacturer
    ELA / SORIN CRM SAS
    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

    RV AND RA INCREASE IN IMPEDANCE, HIGH THRESHOLDS, OVER-SENSING ON RA AND RV. FFRW ON RA, POTENTIAL FOR LOC. 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
    256346 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB ELA / SORIN CRM SAS BT46

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown