BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY? MRI

    MDR report key: 21292420 · Received February 3, 2025

    Report

    Report Number
    2124215-2025-05295
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    January 6, 2025
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526523489
    PMA / PMN Number
    P150012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS AMENDED TO UPDATE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) CODES. INCOMPLETE CODING OF THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH CAPA-8580, WHICH FOCUSED ON IDENTIFYING AND REMEDIATING INCOMPLETE CODING OF EVENTS. ADDED DEVICE CODE A070102. THE LEAD REMAINS IMPLANTED IN THE PATIENT BUT NOT IN USE; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO THE LEAD EXHIBITING HIGH PACING THRESHOLD MEASUREMENTS AND HIGH, OUT OF RANGE PACING IMPEDANCE MEASUREMENTS IN THE BIPOLAR CONFIGURATION. A NEW RV LEAD WAS IMPLANTED DURING A DEVICE REPLACEMENT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO LEAD EXHIBITED HIGH THRESHOLD DUE TO A HIGH IMPEDANCE OUT OF RANGE IN A BIPOLAR SETTING. NEW RIGHT VENTRICULAR (RV) LEAD WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350444 INGEVITY? MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 7742 723919 00802526523489

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H