BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD

    MDR report key: 23707029 · Received December 3, 2025

    Report

    Report Number
    MW5179837
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Report Date
    October 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    Q: IS THERE A CONCERN WITH THIS LEAD WITH LOW PACING IMPEDANCE VALUES AND LOW R WAVES SINCE IT IS ON ADVISORY WITH BOSTON SCIENTIFIC? D: BOSTON SCIENTIFIC 0292 ENDOTAK SINGLE COIL LEAD WITH IMPEDANCES AROUND 68 OHMS IMPLANTED IN 2017. IMPEDANCES AT TIME OF IMPLANT ARE NOT KNOWN. R: NOTED TO CALLER THAT THE BOSTON SCIENTIFIC ADVISORY IS RELATED TO HIGH/RISING DEFIB IMPEDANCE VALUES. THIS LEAD SHOWS LOW TTC PACING IMPEDANCES (190 OHMS IMPEDANCES SINCE AT LEAST 2022). IMPEDANCE VALUES AND R WAVES HAVE REMAINED STABLE BUT LOW IN THIS INTEGRATED BIPOLAR LEAD WITH NO RING ELECTRODE. DEFIB IMPEDANCE SHOWS 66 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
    2829323 LEAD PERMANENT DEFIBRILLATOR ELECTRODES NVY BOSTON SCIENTIFIC CORPORATION 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown