BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

    MDR report key: 1253370 · Received December 2, 2008

    Report

    Report Number
    6000002-2008-09377
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    September 10, 2008
    Report Date
    November 10, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED APPROX AFTER AN IMPLANT DURATION OF 31 MOS, DUE TO UNK REASONS. PT ALSO HAD ANOTHER DEVICE EXPLANTED. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL # 2700, WAS EXPLANTED. REFER TO MFR REPORT# 6000002-2008-09378.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 2700 5L2062

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention