BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 1946150 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20443
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY AND DUE TO THIS, ANALYSIS IS NOT REQUIRED. THE SYSTEM WAS EXPLANTED DUE TO PATIENT INFECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM WAS EXPLANTED DUE TO PATIENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H220

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R H220| 4554| 4135| 0184