BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2010-20637

    MDR report key: 1945793 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20637
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    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 NVN GUIDANT PUERTO RICO BV

    Patients

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