BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1853477 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14768
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PERICARDIAL CENTESIS WAS PERFORMED, WITH AN ESTIMATED 300 CC OF BLOOD EVACUATED FROM THE PERICARDIAL SAC. THE PATIENT WAS OBSERVED OVERNIGHT AND IS NOW REPORTEDLY IN STABLE CONDITION. ALL DIAGNOSTIC MEASUREMENTS WERE WITHIN NORMAL RANGE, AND AVAILABLE INFORMATION SUGGESTS THAT THIS RV LEAD REMAINS IMPLANTED AT THIS TIME. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN INITIAL DEVICE IMPLANT PROCEDURE, WHILE THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD WAS BEING ATTEMPTED, A PERFORATION OCCURRED. THE PERFORATION WAS SUSPECTED WHEN THE PATIENT EXPERIENCED A SIGNIFICANT DROP IN BLOOD PRESSURE, AND WAS CONFIRMED VIA ECHOCARDIOGRAM.

    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 Hospitalization| L| R