BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY?+

    MDR report key: 23196189 · Received October 1, 2025

    Report

    Report Number
    2124215-2025-69521
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    January 4, 2024
    Report Date
    October 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    PMA / PMN Number
    P150012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD WAS FOUND UNRESPONSIVE. WHEN CHECKING THE DATA COLLECTED BY THE DEVICE AN EIGHT-MONTH-OLD ALERT FOR HIGH OUT OF RANGE PACING IMPEDANCES OF 2014 OMHS ON THE RV LEAD WAS ALSO DISCOVERED. TECHNICAL SERVICES (TS) WAS CONSULTED AND IN ANALYZING THE DATA NOTED NOISE WHICH APPEARED TO BE ELECTROMAGNETIC INTERFERENCE (EMI) BEING OVERSENSED ON THE VENTRICULAR CHANNEL. TS AND THE HEALTH CARE PROFESSIONAL (HCP) NOTED THAT THERE APPEARED TO BE NO CORRELATION BETWEEN THE SYMPTOMS THE PATIENT EXPERIENCED AND THE DEVICE. THIS RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307633 INGEVITY?+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7841 1043636

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male