BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 17997056 · Received October 24, 2023

    Report

    Report Number
    2124215-2023-59120
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    October 3, 2023
    Report Date
    October 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604522
    PMA / PMN Number
    P150012/S083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS LEFT BUNDLE PACING (LBP) LEAD WAS PART OF SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LBP LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788703 INGEVITY+ DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 7842 1216859 00802526604522

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| H