BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952816 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24150
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 20, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. DETAILED INSPECTION OF THE LEAD TERMINAL NOTED TWO SETSCREW MARKS. BOTH OF THE SETSCREW MARKS WERE NOT SEATED CORRECTLY ON THE TERMINAL PIN. ANALYSIS CONCLUDED THE EVENT MOST LIKELY OCCURRED DUE TO IMPROPER INSERTION OF THE LEAD INTO THE DEVICE HEADER.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING A REVISION PROCEDURE TO REPLACE THE PREVIOUS RIGHT VENTRICULAR (RV) LEAD, THE LEAD HAD NO PACING OR SENSING. ALSO, SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS WERE RECORDED. THE LEAD WAS REPLACED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1