BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911513 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16297
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 27, 2012
    Report Date
    April 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED THAT THE LEAD WAS RETURNED WITH THE CONNECTOR TOOL NOT SEATED PROPERLY ON THE LEAD, WITH THE FIXATION KNOB ENGAGED, A SET SCREW MARK WAS NOTED ON THE LEAD TERMINAL PIN, DRIED BLOOD/BODY FLUID WAS NOTED IN THE HELIX HOUSING AND THE DISTAL END OF THE PROXIMAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION. RESISTANCE TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. A PRESSURE TEST OF THE OUTER INSULATION WAS NOT PERFORMED DUE TO THE SEPARATION. THE LEAD PASSED THE GUIDEWIRE AND HELIX MECHANISM TESTING. ANALYSIS DID NOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED NO CAPTURE AT HIGH OUTPUTS. THE PHYSICIAN SUSPECTED THAT THE LEAD HAD PERFORATED THE MYOCARDIUM, HOWEVER, THE LEAD WAS NOTED TO BE IN THE SAME POSITION AS IMPLANT. SENSING AND IMPEDANCE MEASUREMENTS WERE NOTED TO BE STABLE AND ACCEPTABLE. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED WITHOUT INCIDENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16983 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R E140| 0295