BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040808 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02023
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    November 7, 2012
    Report Date
    January 2, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    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 ANALYSIS CONFIRMED INSULATION ABRASION ON THE LEAD. DETAILED ANALYSIS OF THE DAMAGE NOTED THE TRILUMEN INSULATION ABRADED THROUGH EXPOSING THE RS- COIL APPROXIMATELY 27.5 CM FROM IS-1 TERMINAL PIN. LABORATORY ANALYSIS CONCLUDED THE DAMAGE WAS MOST LIKELY DUE TO LEAD ON LEAD INTERACTION, AND MAY HAVE RESULTED IN A CONDITION THAT COULD RESULT IN LOSS OF THERAPY ON THE LEAD. RESISTANCE TESTING CONFIRMED THE LEAD CONDUCTOR WAS IN TACT, AND NO OTHER TESTING WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT OVERSENSED NOISE ON THIS RIGHT VENTRICULAR RESULTED IN NUMEROUS INAPPROPRIATE SHOCKS TO BE DELIVERED. THERAPY WAS NOT EXHAUSTED DUE TO THE ISSUE AND NO PACING INHIBITION WAS NOTED. HOWEVER, THE PHYSICIAN ELECTED TO ELECTIVELY REPLACE THE LEAD DUE THE ISSUE. A NEW LEAD WAS IMPLANTED WITH THE CHRONIC DEVICE, AND THE LEAD WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142674 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0186

    Patients

    Seq Age Sex Outcome Treatment
    1