BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 24332159 · Received February 12, 2026

    Report

    Report Number
    MW5183772
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    August 26, 2025
    Report Date
    December 8, 2025
    Manufacturer
    ELA/MICROPORT CRM USA, INC.
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RV POLARITY SWITCH ON (B)(6) 2025. RV PACE/SENSE POLARITY PROGRAMMED UNIPOLAR. SEE LEAD TRENDS. LOW IMPEDANCE. 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
    390450 PERMANENT DEFIBRILLATOR ELECTRODES PERMANENT DEFIBRILLATOR ELECTRODES NVY ELA/MICROPORT CRM USA, INC. P758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown