BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173814 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11167
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    September 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    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 TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE WHEN IMPLANTING THE LEFT VENTRICULAR LEAD THE RIGHT VENTRICULAR LEAD CAME OUT OF ITS ORIGINAL POSITION. AN ATTEMPT TO REPOSITIONING THE RIGHT VENTRICULAR LEAD WAS NOT SUCCESSFULLY AND HIGH OUT OF RANGE PACING IMPEDANCES AND HIGH THRESHOLDS WERE REVEALED. A NEW RIGHT VENTRICULAR LEAD WAS IMPLANTED. THE RIGHT VENTRICULAR LEAD NOT IMPLANTED WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1