BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 3 RF

    MDR report key: 1043375 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33260
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 31, 2008
    Report Date
    January 31, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z-0863-05
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 RF IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention THE DEVICE 0185/151357 WAS IMPLANTED 20-OCT-2006| THE DEVICE 6487 505120 WAS USED DURING THE EVENT.| THE DEVICE 6483 506020 WAS USED DURING THE EVENT.| THE DEVICE 4470/527011 WAS IMPLANTED 20-OCT-2006| THE DEVICE 4525/160685 WAS IMPLANTED 20-OCT-2006| THE DEVICE 6482 009871 WAS USED DURING THE EVENT.