BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL SEPTAL OCCLUDER IMPLANT

    MDR report key: 813375 · Received February 2, 2007

    Report

    Report Number
    MW1041833
    Event Type
    Injury
    Date Received
    February 2, 2007
    Date of Event
    February 1, 2007
    Report Date
    February 2, 2007
    Manufacturer
    MNT MEDICAL INC
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A CARDIOSEAL PFO CLOSURE DEVICE-HDE IMPLANTED IN 2005 FOR PREVIOUS TIA SYMPTOMS. FOR THE LAST TWO WEEKS, PATIENT HAD VISUAL DISTURBANCES AND HAD A CARDIAC ECHO AND TRANS ESOPHAGEAL ECHO -TEE- PERFORMED. TEE SHOWED A MOBILE MASS IN THE LEFT SIDE OF THE HEART, CONNECTED TO THE IMPLANT AREA. CONSULTING CARDIOLOGIST THINKS THAT IT IS EITHER A THROMBUS, WHICH IS A SIDE EFFECT OF THE DEVICE OR A MYXOMA, A BENIGN TUMOR, THAT MAY OCCUR ANYWHERE IN THE BODY. PATIENT IS SCHEDULED TO HAVE AN OPEN HEART SURGERY FOR REMOVAL OF THIS MASS AND IMPLANT. THE REAL DIAGNOSIS WILL BE AVAILABLE AFTER PATHOLOGICAL EXAMINATION OF THE TISSUE AND IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL SEPTAL OCCLUDER IMPLANT * MLV MNT MEDICAL INC * 0407044

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| S