BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY MRI

    MDR report key: 22498218 · Received July 14, 2025

    Report

    Report Number
    2124215-2025-46860
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    July 2, 2025
    Report Date
    July 31, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526569111
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD IS PLANNED TO BE REPLACED DUE TO AN ELECTRODE FRACTURE THAT WAS CONFIRMED BY X-RAY. THE REPLACEMENT PROCEDURE HAS NOT YET BEEN CONFIRMED. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD IS PLANNED TO BE REPLACED DUE TO AN ELECTRODE FRACTURE THAT WAS CONFIRMED BY X-RAY. THE REPLACEMENT PROCEDURE WAS COMPLETED AS PLANNED AND THIS LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD IS PLANNED TO BE REPLACED DUE TO AN ELECTRODE FRACTURE THAT WAS CONFIRMED BY X-RAY. THE REPLACEMENT PROCEDURE WAS COMPLETED AS PLANNED AND THIS LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406025 INGEVITY MRI IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7741 616711 00802526569111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H