BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK CARDIOSEAL

    MDR report key: 515538 · Received March 8, 2004

    Report

    Report Number
    1222632-2004-00003
    Event Type
    Other
    Date Received
    March 8, 2004
    Date of Event
    August 7, 2003
    Report Date
    March 8, 2004
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED TWO EPISODES (6/02 AND TWELVE DAYS LATER) FOLLOWING CARDIOSEAL CLOSURE OF A PFO. PT REPORTED INABILITY TO FOCUS, WEAKNESS AND DIFFICULTY SEEING CLEARLY LASTING 2-3 HRS IN 1ST EPISODE AND LOSS OF VISION IN RIGHT EYE IN SECOND EPISODE. STATED THAT IT FELT LIKE IT DID AFTER THE TIA. IN 2003 PFO CLOSED SURGICALLY AND PT REPORTS TWO ADDITIONAL EPISODES FOLLOWING SURGICAL CLOSURE. HOSPITAL ADVERSE EVENT REPORTED DATED 12/2003 AND RECEIVED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK CARDIOSEAL UNK CARDIOSEAL MLV NMT MEDICAL, INC. UNK CARDIOSEAL *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other