BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 23632696 · Received November 24, 2025

    Report

    Report Number
    MW5179374
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Report Date
    October 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025 15:00:05 RV DEFIB LEAD IMPEDANCE >200 OHMS. (B)(6) 2025 15:00:05 RV DEFIB LEAD IMPEDANCE >200 OHMS. INTERMITTENTLY HIGH RV THRESHOLDS SINCE AT LEAST (B)(6) 2022. DISCUSSED THAT THIS LEAD IS SUBJECT TO RECENT BOSTON SCIENTIFIC ADVISORY. THIS REPORT REFLECTS INFO 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
    314715 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other