BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950811 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22615
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE AND LEADS WERE NOT RETURNED TO BOSTON SCIENTIFIC. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, RIGHT VENTRICULAR DEFIBRILLATION LEAD, AND LEFT VENTRICULAR LEAD WERE REMOVED AND REPLACED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention