BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 16860433 · Received May 3, 2023

    Report

    Report Number
    2124215-2023-21421
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    April 25, 2023
    Report Date
    May 12, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604522
    PMA / PMN Number
    P150012/S083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE PATIENT UNDERWENT AN MRI, IT WAS DISCOVERED THIS RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. THE DISLODGMENT WAS CONFIRMED BY X-RAY IMAGING. THE DEVICE REMAINS IMPLANTED AND AT THIS TIME NO REVISION HAS BEEN SCHEDULED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE PATIENT UNDERWENT AN MRI, IT WAS DISCOVERED THIS RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. THE DISLODGMENT WAS CONFIRMED BY X-RAY IMAGING. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532906 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7842 1044327 00802526604522

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R