BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II EZ STEROX BIPOLAR IS-1 POSITIVE FIX STEROID RA/RV

    MDR report key: 1685144 · Received May 7, 2010

    Report

    Report Number
    2124215-2010-04907
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    February 23, 2010
    Report Date
    May 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II EZ STEROX BIPOLAR IS-1 POSITIVE FIX STEROID RA/RV IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention