BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2153581 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-08214
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATIONS INDICATED THIS LEAD WAS RETURNED IN TWO SEGMENTS. IT APPEARED THAT A PORTION OF THE LEAD MAY HAVE BEEN MISSING. THE STYLET WAS RETURNED STUCK IN THE TIP SEGMENT OF THE LEAD. THE STYLET WAS VERY BENT, AND COULD NOT BE REMOVED WITHOUT DAMAGING THE LEAD FURTHER. TISSUE WAS NOTED ON THE PROXIMAL END OF THE DISTAL SPRING ELECTRODE. THE PROXIMAL END OF THE DISTAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION. AN ABRASION WAS NOTED IN THE EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE). THERE WAS CALCIFIED BODY FLUID ON THE DISTAL TIP. THE CALCIFICATION CREATED A NON-CONDUCTIVE BARRIER BETWEEN THE LEAD HELIX AND THE PATIENT'S HEART TISSUE, THEREBY GRADUALLY INCREASING THE IMPEDANCE SEEN BY THE DEVICE OVER TIME. PRIOR TESTING ON A PASSIVE TIP LEAD HAS SHOWN THAT AS THE CALCIFIED MATERIAL IS REMOVED, THE IMPEDANCE DROPS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THERE WERE 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 0161

    Patients

    Seq Age Sex Outcome Treatment
    1