BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1041659 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34985
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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 68 YR Other THE DEVICE 4513/306544 WAS IMPLANTED 28-NOV-2003| THE DEVICE 4086/203962 WAS IMPLANTED 28-NOV-2003| THE DEVICE 0157/116989 WAS IMPLANTED 28-NOV-2003| THE DEVICE H219/207052 WAS IMPLANTED 31-MAR-2008