BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3232668 · Received July 18, 2013

    Report

    Report Number
    2124215-2013-11376
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2013
    Report Date
    October 8, 2013
    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 RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION OF THE LEAD REVEALED SET SCREW MARKS ON THE TERMINAL. THE MEDICAL ADHESIVE WAS TORN/SEPARATED FROM THE POLYTETRAFLUOROETHYLENE (EPTFE) AT THE PROXIMAL END OF THE PROXIMAL SPRING ELECTRODE AND THE PROXIMAL SPRING WAS STRETCHED AT THIS POINT. THE DISTAL END OF THE PROXIMAL SPRING AND THE PROXIMAL END OF THE DISTAL SPRING ELECTRODE WERE ALSO SEPARATED FROM THE LEAD BODY INSULATION. BLOOD/BODY FLUID IS NOTED IN THE LUMENS AND HELIX HOUSING AND THE HELIX WAS NOTED TO BE RETRACTED. THE LEAD ALSO UNDERWENT A CONTINUITY TEST AND PASSED. DETAILED ANALYSIS FURTHER REVEALED AN ABRADED/TORN EPTFE ON THE SHOCKING CONDUCTOR COIL. TRILUMEN INSULATION DAMAGE WAS ALSO OBSERVED TO BE DUE TO LOCALIZED COMPRESSIVE STRESS ON THE TUBING SURFACE MOST LIKELY CAUSED BY ENTRAPMENT IN THE CLAVICLE/FIRST-RIB REGION. NO FURTHER ISSUES WERE NOTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED AND CURRENTLY UNDERGOING ANALYSIS. THIS REPORT WILL BE UPDATED COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THUS, THE PHYSICIAN DECIDED TO REPOSITION THE LEAD. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE LEAD'S INSULATION WAS HEAVILY DAMAGED BETWEEN THE PATIENT'S RIBCAGE AND CLAVICLE. THE LEAD WAS EXTRACTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD IS NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335631 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R