BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 17608271 · Received August 23, 2023

    Report

    Report Number
    2124215-2023-45613
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 23, 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
    MA, 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 METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA) INFECTION AND SEPSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LBP LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307192 INGEVITY+ DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 7842 1208242 00802526604522

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Hospitalization| R