BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 23372122 · Received October 23, 2025

    Report

    Report Number
    MW5177935
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Report Date
    October 14, 2025
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NVY
    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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM SHOWED NOISE SPIKES AND HAD AN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) EPISODE. THE NOISE HAD ALSO CAUSED BRADY PACING TO NOT BE DELIVERED WHEN REQUIRED. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED EVALUATION OPTIONS FOR THIS SYSTEM. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, AND THIS LEAD HAS BEEN SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL 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
    1402160 PERMANENT DEFIBRILLATOR ELECTRODES PERMANENT DEFIBRILLATOR ELECTRODES NVY BIOTRONIK, INC. 395723

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown