BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX RA/RV 52 CM

    MDR report key: 1383886 · Received February 10, 2009

    Report

    Report Number
    2124215-2009-00130
    Event Type
    Other
    Date Received
    February 10, 2009
    Date of Event
    December 29, 2008
    Report Date
    February 10, 2009
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX RA/RV 52 CM IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR