BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CU[JER SORP;O,IS=E;ITOMG CPRPMARU STEMT

    MDR report key: 622599 · Received July 21, 2005

    Report

    Report Number
    3003742446-2005-01606
    Event Type
    Injury
    Date Received
    July 21, 2005
    Date of Event
    September 8, 2004
    Report Date
    July 21, 2005
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EIGHT MONTHS FOLLOWING CYPHER STENT PLACEMENT IN A SAPHENOUS VEING GRAFT, THE PT PRESENTED FOR FOLLOW UP ANGIOGRAPHY WHICH REVEALED TARGET LESION RESTENOSIS. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. NO DETAILS ARE PROVIDED. LIMITED INDEX PROCEDURE INFORMATION IS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CU[JER SORP;O,IS=E;ITOMG CPRPMARU STEMT DRUG-ELUTING STENT NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R