BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 1853537 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15028
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SUBSEQUENTLY WAS SUCCESSFULLY EXPLANTED WITH NO ADVERSE PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF THE ISSUE, NO ANALYSIS WILL BE CONDUCTED IF THE DEVICE IS RETURNED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS PART OF A PENDING SYSTEM EXPLANT DUE TO A PATIENT INFECTION THAT DEVELOPED FOLLOWING REVISION OF THE PATIENT'S ATRIAL LEAD DUE TO THE EFFECT OF SCAR TISSUE ON LEAD MEASUREMENTS AND FUNCTION. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H227

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other H227| 4592| 4087| 6943