BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2042458 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01124
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    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

    AT THIS TIME THE SYSTEM REMAINS IMPLANTED THUS NO ANALYSIS WILL BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AND INFECTION WAS NOTED. THIS PATIENT IS IMPLANTED WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL, AND RIGHT VENTRICULAR LEADS. A POSSIBLE EXPLANT WILL BE PERFORMED. AT THIS TIME THE SYSTEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1