BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1945754 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20480
    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
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY AND DUE TO THIS, ANALYSIS IS NOT REQUIRED. THE SYSTEM WAS EXPLANTED DUE TO PATIENT INFECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE SYSTEM DEVELOPED ENDOCARDITIS. THE DEVICE AND LEADS WERE TO BE EXPLANTED. NO DEVICE ALLEGATIONS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R T165| 0184| 4470