BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1684091 · Received May 7, 2010

    Report

    Report Number
    2124215-2010-01996
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    January 15, 2010
    Report Date
    May 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 45 YR Required Intervention