BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 4 RF

    MDR report key: 1253658 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40527
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z-0863-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 4 RF IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H235 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THE DEVICE 4524/159462 WAS IMPLANTED 18-JAN-2007| THE DEVICE 4480/476443 WAS IMPLANTED| THE DEVICE 0175/116901 WAS IMPLANTED 18-JAN-2007