BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1873872 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17811
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS ASSOCIATED WITH A SUSPECTED PERFORATION DURING ATTEMPTED IMPLANT. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT FOLLOWING LEAD PLACEMENT IN THE RV APEX, RV THRESHOLDS BEGAN DROPPING WHILE THE LEFT VENTRICULAR GUIDE CATHETER WAS BEING POSITIONED. INVESTIGATION SHOWED LOSS OF RV CAPTURE, AND THE RV LEAD'S POSITION WAS MOVED TO THE MID-SEPTUM AREA. THE PATIENT'S BLOOD PRESSURE DROPPED, AND THE PROCEDURE ENDED WITH CARDIAC TAMPONADE AND ATTEMPTS AT A PERICARDIOCENTESIS. WHEN THAT PROCEDURE CONTINUED TO PULL BLOOD FROM THE SITE, IT WAS ELECTED TO TRANSFER THE PATIENT TO ANOTHER HEALTH CARE FACILITY TO ESTABLISH A PERICARDIAL WINDOW. A PERFORATION IN THE RV APEX WAS CONFIRMED, AND SURGICALLY REPAIRED. THE RV LEAD WAS REPOSITIONED AFTER DISLODGING DURING THE SURGERY, AND THE PROCEDURE WAS COMPLETED WITH IMPLANT OF LEFT VENTRICULAR AND RIGHT ATRIAL LEADS, AND A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS.

    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 Life Threatening| R