BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771529 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12683
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 14, 2010
    Report Date
    July 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN, THIS PRODUCT WAS THOROUGHLY ANALYZED. VISUAL INSPECTION CONFIRMED A COMPLETE LEAD WITH SET SCREW MARKS NOTED ON ALL TERMINAL PINS. CUTS IN THE SUTURE SLEEVE, AS WELL AS SURFACE CUTS, WERE OBSERVED IN THE INSULATION APPROXIMATELY 215-220 MM FROM THE TERMINAL PIN. THE MEDICAL ADHESIVE WAS NOTED TORN/SEPARATED FROM THE EPTFE (EXPANDED POLYTETRAFLUOROETHYLENE) AT THE PROXIMAL END OF THE PROXIMAL SPRING ELECTRODE AND THE PROXIMAL SPRING WAS STRETCHED AT THIS POINT. ADDITIONALLY, INSULATION SLEEVE BUNCHING WAS OBSERVED 285MM AND 320-330MM FROM THE TERMINAL PIN. BLOOD/BODY FLUID WAS CONFIRMED IN THE RATE-SENSE LEAD LUMEN, NOTED FROM THE LEADS TERMINAL PIN TO THE TIP. EXTENSIVE TESTING WAS THEN PERFORMED TO ASSESS THE LEAD'S ELECTRICAL INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS DEMONSTRATED CONTINUITY OF THE ELECTRICAL CIRCUITRY. RIGOROUS TESTING, INCLUDING EXTENSIVE LEAD MANIPULATION WHILE CONNECTED TO AN OHMMETER, VERIFIED THERE WAS NO INTERMITTENCY IN THE ELECTRICAL CONDUCTIVITY. LABORATORY TESTING WAS UNABLE TO VERIFY THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE RIGHT VENTRICULAR (RV) LEAD WAS REPLACED SUCCESSFULLY DUE TO AN INCREASE IN THRESHOLD AND AN INCREASE IN PACING IMPEDANCE GREATER THAN 2000 OHMS. THIS RV LEAD IS INTENDED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. 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 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention