BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1041473 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32057
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    December 27, 2007
    Report Date
    March 27, 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
    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 H177 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention THE DEVICE 1861/219256 WAS IMPLANTED 14-DEC-2001| THE DEVICE 6835/204856 WAS IMPLANTED 05-SEP-2003| THE DEVICE 6481 303054 WAS USED DURING THE EVENT.| THE DEVICE 4538/150624 WAS IMPLANTED 03-SEP-2003| THE DEVICE 1853/401941 WAS IMPLANTED 14-DEC-2001| THE DEVICE 0085/100904 WAS IMPLANTED 03-SEP-2003| THE DEVICE 4054/425800 WAS IMPLANTED 14-DEC-2001| THE DEVICE 0154/349941 WAS IMPLANTED 14-DEC-2001