BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3192733 · Received June 25, 2013

    Report

    Report Number
    2916596-2013-00799
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 27, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS UNDER OBSERVATION IN THE HOSPITAL AND CONTINUES ON LVAD SUPPORT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PERFUSIONIST REPORTED THAT THE PATIENT'S SPEED IS SET AT 9200 BUT DISPLAYING AT 9100-9170. NO CHANGE IN ECHOCARDIOGRAM (ECHO). THE PATIENT HAD AN ISCHAEMIC STROKE A COUPLE OF DAYS AGO ((B)(6) 2013). THE STROKE WAS SIGNIFICANT BUT IS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286890 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 122037

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other