BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMOGRAFT LIFENET AORTIC VALVE

    MDR report key: 545398 · Received August 31, 2004

    Report

    Report Number
    1124603-2004-00002
    Event Type
    Other
    Date Received
    August 31, 2004
    Date of Event
    June 4, 2004
    Report Date
    August 30, 2004
    Manufacturer
    LIFENET
    Product Code
    MIE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A MODIFIED NORWOOD STAGE 1 RECONSTRUCTION WITH 4MM RIGHT VENTRICLE TO PULMONARY ARTERY SANO CONDUIT WITH COMPLETE ATRIAL SEPTECTOMY, ARCH RECONSTRUCTION WITH AORTIC HEMOGRAFT, AS PROTOCOL CULTURES OF GRAFT WERE SENT. NOTIFIED OF + CULTURES 08/2004. >10 COLONIES OF MYCOBACTERIUM GORDONAE ISOLATED. #CULTURES FOR MYCOBACTERIUM ARE PENDING. PT REMAINS HOSPITALIZED. TO DATE, PT HAS RESPONDED TO TREATMENT WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMOGRAFT LIFENET AORTIC VALVE AORTIC VALVE MIE LIFENET 03-3232HV-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L| O