BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1041572 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31961
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    May 24, 2007
    Report Date
    January 25, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z0907/8-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention THE DEVICE 0158/105126 WAS IMPLANTED 03-FEB-2003| THE DEVICE 4513/310119 WAS IMPLANTED 03-FEB-2003| THE DEVICE 4087/153050 WAS IMPLANTED 03-FEB-2003