BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 21164042 · Received January 15, 2025

    Report

    Report Number
    2124215-2025-01654
    Event Type
    Injury
    Date Received
    January 15, 2025
    Date of Event
    December 17, 2024
    Report Date
    April 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604430
    PMA / PMN Number
    P150012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. BASED ON THE FINDING OF A FRACTURED ANODE CONDUCTOR, LOCATED ~213-219 MILLIMETERS (MM) FROM THE TERMINAL END. FRACTURE CHARACTERISTICS ARE CONSISTENT WITH CLAVICLE OR FIRST RIB DAMAGE. LABORATORY TESTING WAS ABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS, AND DETAILED ANALYSIS DID REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO NOISE. THE PHYSICIAN BELIEVED THE ISSUE WAS RELATED TO SUBCLAVIAN CRUSH. A NEW LEAD WAS IMPLANTED. 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 NOISE. THE PHYSICIAN BELIEVED THE ISSUE WAS RELATED TO SUBCLAVIAN CRUSH. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954686 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7840 1061089 00802526604430

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention| H