BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 3 RF

    MDR report key: 1041499 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32027
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    November 30, 2007
    Report Date
    January 28, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    Z-0863-05
    Adverse Event
    Yes
    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 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention THE DEVICE 0157/129192 WAS IMPLANTED 17-JUN-2005| THE DEVICE 4518/326514 WAS IMPLANTED 29-NOV-2007| THE DEVICE 6481 024540 WAS USED DURING THE EVENT.| THE DEVICE T127/102341 WAS IMPLANTED 17-JUN-2005