BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210844 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07368
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. 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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY IMPLANTED. AFTER THE OTHER LEAD MEASUREMENTS WERE OBTAINED, THIS LEAD DISPLAYED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. WITH THE PACING SYSTEM ANALYZER, ACCEPTABLE MEASUREMENTS WERE OBTAINED. A DECISION WAS MADE TO REPLACE THIS LEAD. THIS LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309141 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1