BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1043221 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33414
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 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 72 YR Other THE DEVICE 4512/312748 WAS IMPLANTED 05-FEB-2003| THE DEVICE 6481 034678 WAS USED DURING THE EVENT.| THE DEVICE 0157/106428 WAS IMPLANTED 05-FEB-2003| THE DEVICE 4244/417800 WAS IMPLANTED 07-AUG-2000| THE DEVICE 4035/229753 WAS IMPLANTED 07-AUG-2000| THE DEVICE 0185/120401 WAS IMPLANTED 03-OCT-2005| THE DEVICE 6744/300512 WAS IMPLANTED 07-FEB-2003