BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1043263 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33372
    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
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H135 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other THE DEVICE 4543/130663 WAS IMPLANTED 11-FEB-2008| THE DEVICE H135/775765 WAS IMPLANTED 21-JUL-2003| THE DEVICE 4513/314752 WAS IMPLANTED 21-JUL-2003| THE DEVICE 4470/364908 WAS IMPLANTED 21-JUL-2003| THE DEVICE 6481 032069 WAS USED DURING THE EVENT.| THE DEVICE 0158/106288 WAS IMPLANTED 21-JUL-2003