BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 18035152 · Received October 30, 2023

    Report

    Report Number
    2124215-2023-60442
    Event Type
    Injury
    Date Received
    October 30, 2023
    Date of Event
    October 23, 2023
    Report Date
    January 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604577
    PMA / PMN Number
    P150012/S083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. ENVIRONMENTAL STRESS CRACKING (ESC) WAS OBSERVED AT APPROXIMATELY 180 FROM THE TERMINAL PIN, ON THE SURFACE ONLY. NOTED DEFORMED COILS AT APPROXIMATELY 120, 193, AND 200 MM FROM THE TERMINAL END. THE OUTER COIL CONDUCTOR RESISTANCE MEASURED AS AN ELECTRICAL OPEN, INDICATING A FRACTURED OR BROKEN CONDUCTOR. A FRACTURED OUTER COIL CONDUCTOR WAS OBSERVED AT APPROXIMATELY 193 MM FROM THE TERMINAL END. FRACTURE CHARACTERISTICS ARE CONSISTENT WITH CLAVICLE/FIRST RIB DAMAGE. COILS ARE STRETCHED AND WHITE RESIDUE AT FRACTURE SITE. AN X-RAY CONFIRMED OUTER COIL FRACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED DUE TO LEAD FRACTURE CAUSING HIGH IMPEDANCE MEASUREMENTS OF OVER 3000 OHMS. 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 LEAD FRACTURE CAUSING HIGH IMPEDANCE MEASUREMENTS OF OVER 3000 OHMS. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1981847 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7841 1157914 00802526604577

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| R