BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1033796 · Received April 24, 2008

    Report

    Report Number
    6000002-2008-06629
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 25, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS; HOWEVER, THE REASON FOR EXPLANT IS UNKNOWN. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 3000TFX R-07M2442

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention