BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1864696 · Received October 12, 2010

    Report

    Report Number
    2124215-2010-16577
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    March 26, 2010
    Report Date
    August 5, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE COMPLETE LEAD WAS RETURNED. ELECTRICAL TESTING PERFORMED ON THE LEAD REVEALED THAT THE LEAD WAS NOT ELECTRICALLY CONTINUOUS DUE TO A FRACTURED OUTER RS+ CONDUCTOR COIL 27MM FROM THE TERMINAL PIN. ALTHOUGH NOT CONFIRMED, IT IS POSSIBLE THAT THE FRACTURED RS+ CONDUCTOR COIL COULD HAVE CONTRIBUTED TO THE CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN INCREASE IN PACING IMPEDANCES AS WELL AS NOISE AND OVERSENSING WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. ANALYSIS OF SEVERAL EPISODES BY TECHNICAL SERVICES DISCUSSED POSSIBLE INDICATIONS REGARDING THE CLINICAL OBSERVATIONS. SUBSEQUENTLY, A REVISION TOOK PLACE AND THIS LEAD WAS RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 38 YR 0148| F102| 1870