BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 17017832 · Received May 30, 2023

    Report

    Report Number
    2124215-2023-27078
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    May 9, 2023
    Report Date
    June 19, 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
    CA, 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.

    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 SYSTEM WITH A RIGHT VENTRICULAR (RV) LEAD AND AN OFF LABEL IMPLANTED LEFT BUNDLE BRANCH (LBB) LEAD SHOWED NON PHYSIOLOGIC NOISE OVER SENSING. VARIOUS ORIGINS WERE DISCUSSED FOR THIS ISSUE BUT ACCORDING TO THE FIELD REPRESENTATIVE IT WAS DETERMINED THAT THE LBB LEAD WAS TAPPING ON THE RV COIL. IT WAS RECOMMENDED TO REPOSITION THE LBB LEAD. BOTH LEADS REMAIN IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SYSTEM WITH A RIGHT VENTRICULAR (RV) LEAD AND AN OFF LABEL IMPLANTED LEFT BUNDLE BRANCH (LBB) LEAD SHOWED NON PHYSIOLOGIC NOISE OVER SENSING. VARIOUS ORIGINS WERE DISCUSSED FOR THIS ISSUE BUT ACCORDING TO THE FIELD REPRESENTATIVE IT WAS DETERMINED THAT THE LBB LEAD WAS TAPPING ON THE RV COIL. IT WAS RECOMMENDED TO REPOSITION THE LBB LEAD. BOTH LEADS REMAIN IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE MENTIONING THAT THE SLACK IN THE LBB LEAD WAS PULLED BACK, ELIMINATING CONTACT WITH RV COIL AT THE SAME INITIAL PROCEDURE, BEFORE POCKET CLOSURE. THE LBB LEAD TAPPING THE RV COIL WAS OBSERVED VIA X RAY IN MULTIPLE VIEWS. THE PATIENT WAS FULLY RECOVERED FROM THE PROCEDURE AND THE LEADS REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553047 INGEVITY+ IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7842 1191698 00802526604522

    Patients

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