BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS HE IS-1/DF-1/IS-1

    MDR report key: 1253888 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40756
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS HE IS-1/DF-1/IS-1 IMPLANTABLE CHF PULSE GENERATOR NIK CARDIAC PACEMAKERS, INC N119 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention THE DEVICE 4555/170076 WAS IMPLANTED 16-SEP-2008| THE DEVICE 6947/TDG012 WAS IMPLANTED 16-AUG-2002| THE DEVICE 4549/157937 WAS IMPLANTED 16-SEP-2008