BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 2992173 · Received March 7, 2013

    Report

    Report Number
    3007042319-2013-00027
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 18, 2012
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO EXPERIENCED RE-OCCURRING "STROKE-LIKE" SYMPTOMS APPROXIMATELY FOUR AND A HALF MONTHS AFTER HEARTWARE LVAD IMPLANTATION. THE PATIENT'S ASPIRIN WAS DECREASED (81MG) AND SHE WAS STARTED ON PLAVIX (75MG). THE PATIENT IS THEN REPORTED TO HAVE DEVELOPED A HEADACHE AND A REPEATED CT REVEALED A SMALL TO MODERATE AMOUNT OF SUBARACHNOID BLOOD BETWEEN THE SULCI OF THE RIGHT HEMISPHERE AND A FOCAL HEMORRHAGE IN THE RIGHT FRONTAL LOBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96728 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S ASPIRIN (325MG)