BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1202920 · Received October 17, 2008

    Report

    Report Number
    3001743903-2008-00053
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT DEVELOPED ENDOCARDITIS 3 MONTHS POST-OP. THE PT HAD SEVERE AORTIC INSUFFICIENCY AND ACCORDING TO THE PHYSICIAN, IT WAS A DIFFICULT RE-OPERATION. THE VALVE WAS REPLACED WITH A HOMOGRAFT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE LWR ST JUDE MEDICAL BRASIL LTDA B10-27A-00

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R