BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 3 RF HE

    MDR report key: 1043607 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33044
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    January 31, 2008
    Report Date
    January 31, 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
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 RF HE IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H219 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other THE DEVICE 6482 025870 WAS USED DURING THE EVENT.| THE DEVICE 0158/152850 WAS IMPLANTED 13-JUN-2005| THE DEVICE 6487 507030 WAS USED DURING THE EVENT.| THE DEVICE 6483 507020 WAS USED DURING THE EVENT.| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 4513/408154 WAS IMPLANTED 12-SEP-2005