BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY?+

    MDR report key: 20403128 · Received October 8, 2024

    Report

    Report Number
    2124215-2024-62954
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 12, 2024
    Report Date
    April 30, 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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 PATIENT CODE E060104. THE LEAD REMAINS IMPLANTED AND IN SERVICE; 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 THE NEWLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD WAS DISCOVERED TO BE DISLODGED, AND THAT THE PATIENT HAD BEEN NON-COMPLIANT WITH REGARD TO ARM MOVEMENT FOLLOWING THE PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD ENTERED ATRIAL FIBRILLATION (ASYMPTOMATIC) THE DAY AFTER IMPLANT, THOUGH IT WAS NOT SPECIFIED WHETHER THE DISLODGED LEAD HAD CONTRIBUTED TO THE ARRHYTHMIA. ADDITIONALLY, THE PATIENT HAD HEART RATES IN THE LOW 30 TO UPPER 40 BPM RANGE. THE RV LEAD WAS REPOSITIONED ON (B)(6) 2024, AND THE PATIENT WAS SENT HOME WITH AN ARM BRACE. THE PATIENT WAS SUBSEQUENTLY SEEN IN-CLINIC WITH A GOOD OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEWLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD WAS DISCOVERED TO BE DISLODGED, AND THAT THE PATIENT HAD BEEN NON-COMPLIANT WITH REGARD TO ARM MOVEMENT FOLLOWING THE PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD ENTERED ATRIAL FIBRILLATION (ASYMPTOMATIC) THE DAY AFTER IMPLANT, THOUGH IT WAS NOT SPECIFIED WHETHER THE DISLODGED LEAD HAD CONTRIBUTED TO THE ARRHYTHMIA. THE RV LEAD WAS REPOSITIONED ON (B)(6) 2024, AND THE PATIENT WAS SENT HOME WITH AN ARM BRACE. THE PATIENT WAS SUBSEQUENTLY SEEN IN-CLINIC WITH A GOOD OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142541 INGEVITY?+ DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 7842 1348143 00802526604522

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Hospitalization| R