BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3 RF

    MDR report key: 1042689 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33944
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    NA
    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 69 YR Other THE DEVICE 4469/485980 WAS IMPLANTED 09-OCT-2007| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 0184/137215 WAS IMPLANTED 09-OCT-2007| THE DEVICE 4554/154888 WAS IMPLANTED 09-OCT-2007| THE DEVICE 6482 023646 WAS USED DURING THE EVENT.| THE DEVICE 6487 507020 WAS USED DURING THE EVENT.| THE DEVICE 6483 505120 WAS USED DURING THE EVENT.