BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC SUPRA STENTED PORCINE HEART VALVE

    MDR report key: 3032230 · Received March 29, 2013

    Report

    Report Number
    3001883144-2013-00002
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    November 30, 2012
    Report Date
    March 5, 2013
    Manufacturer
    ST. JUDE MEDICAL BRASIL LTDA. (PAMPULHA)
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE THE VALVE REMAINS IMPLANTED. HOWEVER, THERE WAS NO EVIDENCE FOUND TO SUGGEST THERE WAS AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY REVIEW OF THE VALVE'S DEVICE HISTORY RECORD. THE CAUSE OF THE SUSPECTED ENDOCARDITIS AND POSITIVE BLOOD CULTURES FOR ESCHERICHIA COLI REMAINS UNK.

    Description of Event or Problem · 1

    ENDOCARDITIS WAS SUSPECTED DUE TO POSITIVE BLOOD CULTURES SHOWING ESCHERICHIA COLI AND ANTIBIOTIC TREATMENT WAS STARTED. PRIOR TO THE PT'S DISCHARGE THE VALVE SHOWED NO VEGETATION OR SIGNS OF ENDOCARDITIS. THE PHYSICIAN STATED THAT THE PREVIOUS DIAGNOSIS OF ENDOCARDITIS WAS UNLIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131033 SJM EPIC SUPRA STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL BRASIL LTDA. (PAMPULHA) ESP100-25

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R