BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1043476 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33165
    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
    Z47/55-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 63 YR Required Intervention THE DEVICE 4469/454592 WAS IMPLANTED 03-MAR-2006| THE DEVICE 0184/120029 WAS IMPLANTED 03-MAR-2006| THE DEVICE 4517/418921 WAS IMPLANTED 03-MAR-2006