BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1873876 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17869
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM AN OUT-OF-SERVICE FORM THAT THIS PATIENT'S DEVICE AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R 0185| T175