BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2143046 · Received June 23, 2011

    Report

    Report Number
    2916596-2011-00260
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISPOSED OF AND THEREFORE, WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS EXPERIENCING HEMOLYSIS. THERE WAS NO CHANGE IN THE PATIENT'S PUMP POWER NOTED. THE PATIENT WAS ASYMPTOMATIC. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT WAS READMITTED INTO THE HOSPITAL APPROXIMATELY TWO WEEKS LATER FOR ARM NUMBNESS. A FEW ISOLATED POWER SPIKES WERE NOTED. THE RESULTS OF THE HEAD CT SCAN PERFORMED SHOWED HEMORRHAGE. THE HOSPITAL STAFF EXCHANGED THE PUMP DUE TO SUSPECTED THROMBUS. THE PATIENT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 95654

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention