BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND 2 IS-1 BI POSITIVE FIX RA/RV 59 CM

    MDR report key: 1684317 · Received May 7, 2010

    Report

    Report Number
    2124215-2010-02252
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    January 5, 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 FLEXTEND 2 IS-1 BI POSITIVE FIX RA/RV 59 CM IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4097 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other