BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3 RF

    MDR report key: 1043307 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33332
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 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 Other THE DEVICE 4087/268348 WAS IMPLANTED 19-JUL-2007| THE DEVICE 6487 507020 WAS USED DURING THE EVENT.| THE DEVICE 0158/168268 WAS IMPLANTED 19-JUL-2007| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6482 019020 WAS USED DURING THE EVENT.| THE DEVICE 4555/160531 WAS IMPLANTED 19-JUL-2007| THE DEVICE 6483 507020 WAS USED DURING THE EVENT.