BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 19668349 · Received July 2, 2024

    Report

    Report Number
    MW5156995
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Report Date
    May 23, 2024
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS NOT PERFORMING AS EXPECTED. TECHNICAL SERVICES (TS) ANALYZED DEVICE DATA AND FOUND THAT THE PACING IMPEDANCE OF THE RV LEAD HAD GRADUALLY DECREASED UNTIL 426 OHMS AT MOST RECENT MEASUREMENT. THERE WERE STORED VENTRICULAR EPISODES DUE TO OVERSENSING OF NON-PHYSIOLOGICAL NOISE ON THE RV CHANNEL. DURING ONE EPISODE, THE RV LEAD WAS UNDER-SENSING THE WIDE COMPLEX RHYTHM. IT WAS NOTED THAT THE PATIENT'S INTRINSIC R-WAVE WAS VARYING FROM 1.2MV TO 25MV. TS RECOMMENDED ISOMETRIC TESTING AND X-RAY, BUT IT WAS NOTED THAT A LEAD REVISION HAS BEEN SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS (RIGHT VENTRICULAR) RV LEAD REMAINS IN SERVICE. 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
    170363 PERMANENT DEFIBRILLATOR ELECTRODES PERMANENT DEFIBRILLATOR ELECTRODES NVY BIOTRONIK, INC. PROTEGO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown