BEUDAMED
    FDA Adverse Event Other Summary report: N

    COGNIS HE IS-1/DF-1/IS-1 - INTL (EU ONLY) MARKET RELEASED

    MDR report key: 1534828 · Received November 10, 2009

    Report

    Report Number
    2124215-2009-15221
    Event Type
    Other
    Date Received
    November 10, 2009
    Date of Event
    July 9, 2009
    Report Date
    November 10, 2009
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS HE IS-1/DF-1/IS-1 - INTL (EU ONLY) MARKET RELEASED IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107 NA

    Patients

    Seq Age Sex Outcome Treatment
    1