BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1218201 · Received October 29, 2008

    Report

    Report Number
    6000002-2008-09099
    Event Type
    Injury
    Date Received
    October 29, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 16, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED ON 10/24/2008, HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 31 MONTHS, DUE TO MITRAL REGURGITATION. REPORTEDLY, THE PATIENT EXPERIENCED DIZZINESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 6900P 5G1172

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VANCOMYCIN: 1000 MG - 2 DAYS