BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1861054 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15355
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE EXPLANTED LEAD IS RETURNED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, THE CLINICAL OBSERVATIONS WERE CONFIRMED. VISUAL INSPECTION OF THE LEAD CONFIRMED INSULATION DAMAGE, AND MELTED METAL FROM ARCING DAMAGE. DUE TO THE LOCATION OF THE LEAD AND THE TYPE OF DAMAGE INCURRED IT IS LIKELY THE INSULATION DAMAGE WAS CAUSED BY ENTRAPMENT IN THE CLAVICLE/ FIRST-RIB REGION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THIS CHRONIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS EXPLANTED AND REPLACED AFTER BEING ASSOCIATED WITH TWO WARNING MESSAGES DURING DEFIBRILLATION THRESHOLD (DFT) TESTING. INITIALLY, THE ASSOCIATED DEVICE DISPLAYED A MESSAGE INDICATING A LOW SHOCK IMPEDANCE CONDITION, AND THEN A MESSAGE INDICATING A SHORTED LEAD CONDITION EXISTED. THE PATIENT WAS EXTERNALLY RESCUED WITH NO ADVERSE EFFECTS.

    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 54 YR Required Intervention 4018| 4017| 0148