BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL 2

    MDR report key: 1254102 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40915
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    NIK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 2 IMPLANTABLE CHF GENERATOR NIK CARDIAC PACEMAKERS, INC H155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other