BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE 2 EZ

    MDR report key: 1255053 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-38537
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 11, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    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 THINLINE 2 EZ IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 438-35S-58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE 4470/602489 WAS IMPLANTED 10-JUL-2008