BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 21627636 · Received March 17, 2025

    Report

    Report Number
    2124215-2025-16606
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    February 19, 2025
    Report Date
    June 17, 2025
    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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP NOTED DEFORMED COILS FROM THE TERMINAL END AND TISSUE STUCK IN THE HELIX. BASED ON THE FIELD REPORT, PERFORATION, PERICARDIAL EFFUSION, AND CARDIAC TAMPONADE ARE KNOWN RISKS ASSOCIATED WITH MEDICAL PROCEDURES INVOLVING IMPLANTED CARDIAC LEADS. THE ANALYSIS OF THE RETURNED PRODUCT CANNOT PROVIDE RELEVANT INFORMATION FOR THESE TYPES OF ALLEGATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO A MICRO DISLODGMENT WHICH WAS CONFIRMED THROUGH A CHEST X-RAY. A NEW RA LEAD WITH A DIFFERENT MODEL WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO A MICRO DISLODGMENT WHICH WAS CONFIRMED THROUGH A CHEST X-RAY. A NEW RA LEAD WITH A DIFFERENT MODEL WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805414 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7841 1509531 00802526604577

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization| R