BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040733 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02048
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON 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 THE PRESENCE OF A SET SCREW MARK ON THE LEAD TERMINAL PIN, A CUT WAS OBSERVED IN THE LEAD AND THE SUTURE SLEEVE, DRIED BLOOD/BODY FLUID WAS NOTED IN THE LUMEN AND IN THE HELIX HOUSING. RESISTANCE TESTING AND A PRESSURE TEST OF THE INNER INSULATION WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. GUIDEWIRE TESTING AND A PRESSURE TEST OF THE OUTER INSULATION WAS NOT PERFORMED DUE TO THE CUT IN THE LEAD BODY AND PRESENCE OF BLOOD/BODY FLUID. LABORATORY ANLAYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE DEFIBRILLATION LEAD PRESENTED FOR A ROUTINE IN-CLINIC FOLLOW UP WITH COMPLAINT OF CHEST PAIN. THE LEAD EXHIBITED LOSS OF CAPTURE (LOC) AT HIGH OUTPUTS. A LEAD PERFORATION WAS SUSPECTED. AN ECHOCARDIOGRAM WAS PERFORMED AND NO PERICARDIAL EFFUSION WAS OBSERVED, HOWEVER, A PERFORATION WAS UNDETERMINED. AN INVASIVE PROCEDURE WAS PERFORMED. AN ATTEMPT TO REPOSITION THE LEAD WAS MADE, HOWEVER, LOC WAS OBSERVED IN ALL LOCATIONS. THE LEAD WAS EXPLANTED AND REPLACED. DURING INITIAL IMPLANT OF THE REPLACEMENT LEAD, LOC WAS OBSERVED. THE LEAD WAS REPOSITIONED AND CAPTURE WAS OBTAINED. THE PHYSICIAN SUSPECTED A POTENTIAL INFARCT. 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
    144040 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R 0295| 4469| E162