BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1945746 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20635
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST WAS MADE FOR PRODUCT RETURN. INVESTIGATION HAS BEEN COMPLETED TO THIS POINT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), DEFIBRILLATION, AND TRANSVENOUS LEADS WERE EXPLANTED. THE LEFT VENTRICULAR LEAD, REQUIRING AND ADAPTER, WAS CUT AND SURGICALLY ABANDONED. THIS ALL OCCURRED DUE TO A PATIENT'S INFECTION AND EROSION RELATED TO THESE PRODUCTS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention H179| 0158| 4513| 4512| 4470| 4402| 4047| H219