BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 20123444 · Received September 3, 2024

    Report

    Report Number
    2124215-2024-54810
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    August 5, 2024
    Report Date
    September 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604522
    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 VENTRICULAR (RV) LEAD HAD PACING FAILURE AFTER IMPLANTATION AND ALSO EXHIBITED HIGH PACING THRESHOLDS. IN ADDITION, THE PHYSICIAN BELIEVES THAT IT WAS DUE TO DISLODGEMENT. THIS LEAD WAS SURGICALLY REVISE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD PACING FAILURE AFTER IMPLANTATION AND ALSO EXHIBITED HIGH PACING THRESHOLDS. IN ADDITION, THE PHYSICIAN BELIEVES THAT IT WAS DUE TO DISLODGEMENT. THIS LEAD WAS SURGICALLY REVISE AND REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899505 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7842 1298756 00802526604522

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| H