BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL 4

    MDR report key: 1042197 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34459
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 4 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H197 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE 4542/114426 WAS IMPLANTED| THE DEVICE 4480/477178 WAS IMPLANTED| THE DEVICE 0154/359738 WAS IMPLANTED