BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2800937 · Received October 18, 2012

    Report

    Report Number
    2916596-2012-00979
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE CARDIOLOGIST REPORTED THAT THE PT WAS ADMITTED WITH SEVERE HEMOLYSIS REQUIRING SEVERAL TRANSFUSIONS. THE PT ALSO STARTED HAVING INTERMITTENT LOW FLOW ALARMS. THE PT DID NOT HAVE ANY HISTORY OF POWER ELEVATIONS. A PUMP EXCHANGE WAS PERFORMED, BUT THE INLET AND OUTLET PORTIONS REMAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 113238

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention