BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOSEAL OCL-028-PFO

    MDR report key: 358838 · Received October 29, 2001

    Report

    Report Number
    1222632-2001-00018
    Event Type
    Death
    Date Received
    October 29, 2001
    Date of Event
    July 20, 2001
    Report Date
    October 25, 2001
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WITH A HISTORY OF DIABETES AND SEIZURE DISORDER, WHO RESIDED IN A CUSTODIAL HOME DUE TO MODERATELY SEVERE MENTAL RETARDATION. TO REDUCE THEIR RECURRENT STROKE RISK, THEY UNDERWENT "PFO" CLOSURE IN 2000 AND WAS SENT TO REHAB ON ANTIPLATELET THERAPY. PT WAS READMITTED TO STROKE SERVICES IN 2001 WITH NAUSEA AND VOMITING, PNEUMONIA, FOLLOWED BY DECLINING MENTAL STATUS AND RESPIRATORY FAILURE. PT EXPIRED 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48445 CARDIOSEAL OCL-028-PFO CARDIOSEAL MLV NMT MEDICAL, INC. OCL-028-PFO 0004147

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death