BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1043471 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33160
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 5, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z47/53-08
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H170 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention THE DEVICE 0154/342310 WAS IMPLANTED 28-SEP-2000| THE DEVICE 4054/414688 WAS IMPLANTED 28-SEP-2000| THE DEVICE 4543/101139 WAS IMPLANTED 25-AUG-2004