BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3 RF HE

    MDR report key: 1042390 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34261
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z47/55-07
    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 HE IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H217 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other THE DEVICE 6487 507030 WAS USED DURING THE EVENT.| THE DEVICE 4047/105894 WAS IMPLANTED 06-FEB-2006| THE DEVICE 6482 002305 WAS USED DURING THE EVENT.| THE DEVICE 4087/246733 WAS IMPLANTED 03-FEB-2006| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 4047/105895 WAS IMPLANTED 06-FEB-2006| THE DEVICE 6483 506010 WAS USED DURING THE EVENT.| THE DEVICE 0158/159350 WAS IMPLANTED 03-FEB-2006| THE DEVICE 6487 506010 WAS USED DURING THE EVENT.