BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1043102 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33547
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H179 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 4518/305845 WAS IMPLANTED 29-OCT-2004| THE DEVICE 4471/419916 WAS IMPLANTED 29-OCT-2004| THE DEVICE 0185/105309 WAS IMPLANTED 29-OCT-2004| THE DEVICE 6481 048090 WAS USED DURING THE EVENT.