BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY?+

    MDR report key: 21956285 · Received May 4, 2025

    Report

    Report Number
    2124215-2025-28388
    Event Type
    Injury
    Date Received
    May 4, 2025
    Date of Event
    April 5, 2025
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604577
    PMA / PMN Number
    P150012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 PATIENT CODE E233001. THE DEVICE REMAINS IMPLANTED AND IN SERVICE; 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 THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY REVISED DUE TO DISLODGMENT THAT WAS CONFIRMED VIA X-RAY. THE PATIENT HAD REPORTED CHEST PAIN. THIS RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY REVISED DUE TO DISLODGMENT THAT WAS CONFIRMED VIA X-RAY. HENCE, THE PATIENT EXPERIENCED CHEST PAIN. THIS RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507669 INGEVITY?+ DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 7841 1589555 00802526604577

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Hospitalization| R