BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY?+

    MDR report key: 20686140 · Received November 14, 2024

    Report

    Report Number
    2124215-2024-71718
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    October 17, 2024
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526604522
    PMA / PMN Number
    P150012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS AMENDED TO UPDATE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) CODES. INCOMPLETE CODING OF THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH CAPA-8580, WHICH FOCUSED ON IDENTIFYING AND REMEDIATING INCOMPLETE CODING OF EVENTS. ADDED DEVICE CODE A070101 AND IMPACT CODE F2203. THE LEAD WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS BRADY LEAD THAT WAS IMPLANTED IN THE LEFT BUNDLE BRANCH (LBB) EXHIBITED LEAD DISLODGEMENT, CONFIRMED VIA FLUOROSCOPY. TESTING OF THE LEAD FOUND LOSS OF CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED WITH ONE OF THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS BRADY LEAD THAT WAS IMPLANTED IN THE LEFT BUNDLE BRANCH EXHIBITED LEAD DISLODGEMENT. THIS BRADY LEAD WAS EXPLANTED AND REPLACED WITH THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390467 INGEVITY?+ DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 7842 1385990 00802526604522

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R