BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 17216577 · Received June 28, 2023

    Report

    Report Number
    2124215-2023-33628
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 6, 2023
    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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS FOUND TO HAVE DISLODGED THE SAME DAY IT WAS IMPLANTED, WITH NO ADVERSE EFFECTS REPORTED AND THE DISLODGMENT WAS CONFIRMED BY X-RAY IMAGING. A LEAD REVISION WAS PERFORMED AND THIS LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS FOUND TO HAVE DISLODGED THE SAME DAY IT WAS IMPLANTED, WITH NO ADVERSE EFFECTS REPORTED AND THE DISLODGMENT WAS CONFIRMED BY X-RAY IMAGING. A LEAD REVISION WAS PERFORMED AND THIS LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS FOUND TO HAVE DISLODGED THE SAME DAY IT WAS IMPLANTED, WITH NO ADVERSE EFFECTS REPORTED AND THE DISLODGMENT WAS CONFIRMED BY X-RAY IMAGING. A LEAD REVISION WAS PERFORMED AND THIS LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151074 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7841 1278120 00802526604577

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention| H