BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 3 RF

    MDR report key: 1042567 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34074
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z-0863-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 65 YR Required Intervention THE DEVICE 0184/126557 WAS IMPLANTED 11-AUG-2006| THE DEVICE 4548/151489 WAS IMPLANTED 11-AUG-2006| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6482 025985 WAS USED DURING THE EVENT.