BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1254120 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40954
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z47/55-07
    Adverse Event
    Yes
    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 3 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention THE DEVICE 0155/354579 WAS IMPLANTED 10-DEC-2002| THE DEVICE 4470/341304 WAS IMPLANTED 10-DEC-2002| THE DEVICE 6481 022890 WAS USED DURING THE EVENT.| THE DEVICE 4513/312644 WAS IMPLANTED 10-DEC-2002