BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE VE LVAS

    MDR report key: 234960 · Received August 6, 1999

    Report

    Report Number
    1218444-1999-00013
    Event Type
    Injury
    Date Received
    August 6, 1999
    Date of Event
    July 8, 1999
    Report Date
    July 9, 1999
    Manufacturer
    THERMO CARDIOSYSTEMS INC.
    Product Code
    DSQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 1999, THE PATIENT WAS IMPLANTED WITH AN LVAD, BUT DID NOT WAKE UP POST-OP AS EXPECTED. ON 07/09/1999, THE CARDIOLOGIST REPORTED THAT HE VISUALIZED A LARGE VOLUME OF AIR COME FROM THE APEX OF THE VENTRICLE NEAR OR AT THE LVAD INFLOW CANULA GO THROUGH THE AORTIC VALVE AND OUT INTO THE AORTA. THE PATIENT WAS IN THE UNIT WITH GOOD FLOWS THOUGH THE LVAD, BUT WAS SEIZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE VE LVAS Implant LEFT VENTRICULAR ASSIST DEVICE DSQ THERMO CARDIOSYSTEMS INC. 1212 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening