BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 22001796 · Received May 12, 2025

    Report

    Report Number
    2124215-2025-30222
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    April 8, 2025
    Report Date
    September 1, 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
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS THOROUGHLY ANALYZED. VISUAL INSPECTION CONFIRMED THAT THE WHOLE LEAD WAS RETURNED. THE HELIX WAS RETRACTED AND THERE WAS DRIED BLOOD/TISSUE WITHIN THE HELIX HOUSING. RESISTANCE TESTING FOUND THAT THE LEAD WAS NOT ELECTRICALLY CONTINUOUS. DETAILED ANALYSIS CONFIRMED THAT THE OUTER CONDUCTOR COIL HAD A BREAK APPROXIMATELY 252-254 MILLIMETERS FROM THE TERMINAL END. BASED ON THE CHARACTERISTICS OF THE FRACTURE, IT WAS DETERMINED THAT IT WAS CONSISTENT WITH CYCLIC FATIGUE DAMAGE. ANALYSIS CONCLUDED THAT THE CLINICAL OBSERVATIONS WERE LIKELY CAUSED BY THE CONFIRMED FRACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE OUT OF RANGE AT 3000 OHMS IN UNIPOLAR WHICH WAS CONFIRMED VIA X RAY DUE TO LEAD BREAKAGE OR FRACTURE. THIS RA LEAD WAS EXPLANTED AND REPLACED WITH THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE OUT OF RANGE AT 3000 OHMS IN UNIPOLAR WHICH WAS CONFIRMED VIA X RAY DUE TO LEAD BREAKAGE OR FRACTURE. THIS RA LEAD WAS EXPLANTED AND REPLACED WITH THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389790 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7841 1521211 00802526604577

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| H