BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1944565 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19657
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 7, 2010
    Report Date
    October 7, 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

    THIS RV LEAD WAS EXPLANTED, BUT WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND ASSOCIATED DEVICE WERE EXPLANTED DUE TO INFECTION. THERE WERE NO ALLEGATIONS AGAINST THIS LEAD AND ASSOCIATED DEVICE, AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1