BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 3 RF

    MDR report key: 1043388 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33245
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    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 H210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention THE DEVICE 0185/178657 WAS IMPLANTED 24-JAN-2008| THE DEVICE 1274/502176 WAS IMPLANTED 16-JUL-2004| THE DEVICE 4457/442066 WAS IMPLANTED 28-JUL-2004| THE DEVICE 4470/564517 WAS IMPLANTED 24-JAN-2008| THE DEVICE 4480/431623 WAS IMPLANTED 28-JUL-2004| THE DEVICE 4269/007064 WAS IMPLANTED 13-DEC-1990| THE DEVICE 1230/501898 WAS IMPLANTED 18-FEB-1999