BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT

    MDR report key: 2850558 · Received November 16, 2012

    Report

    Report Number
    2648612-2012-00058
    Event Type
    Injury
    Date Received
    November 16, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED WITH FEVER, BACK PAIN AND CHILLS. CULTURE RESULTS WERE POSITIVE FOR INFECTION AND A RE-DO OPERATION WAS PERFORMED IN (B)(6) 2012 (EXACT DATE UNK). ANOTHER MANUFACTURER'S GRAFT WAS IMPLANTED. THE PT REMAINS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT AORTIC VALVED GRAFT LWQ ST. JUDE MEDICAL PUERTO RICO, INC. (CS) 29VAVGJ-515

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R