BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNERGRAFT PULMONARY VALVE AND CONDUIT

    MDR report key: 1669613 · Received April 16, 2010

    Report

    Report Number
    1063481-2010-00010
    Event Type
    Other
    Date Received
    April 16, 2010
    Date of Event
    March 23, 2010
    Report Date
    April 16, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SYNERGRAFT PULMONARY VALVE AND CONDUIT WAS EXPLANTED ONE YEAR POST-OPERATIVELY DUE TO PULMONARY INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGRAFT PULMONARY VALVE AND CONDUIT HEART VALVE ALLOGRAFT MIE CRYOLIFE, INC. SGPV00

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO Other