BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

    MDR report key: 1040570 · Received May 9, 2008

    Report

    Report Number
    6000002-2008-07148
    Event Type
    Death
    Date Received
    May 9, 2008
    Date of Event
    October 7, 2007
    Report Date
    April 10, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF ONE MONTH, DUE TO UNKNOWN REASONS. UNKNOWN IF THE DEVICE WAS EXPLANTED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 2700 R-07G1391

    Patients

    Seq Age Sex Outcome Treatment
    1 Death