BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2944022 · Received January 31, 2013

    Report

    Report Number
    2916596-2013-00103
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    January 10, 2003
    Report Date
    January 10, 2003
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD AND SYSTEM CONTROLLER WERE RETURNED TO THE MFR FOR EVAL AND ARE 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 VAD COORDINATOR REPORTED THAT THE PT WAS ADMITTED TO THE EMERGENCY ROOM WITH LOW FLOWS AND A PUMP STOP. THE PUMP WAS EXCHANGED DUE TO SUSPECTED THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42283 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 114831

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention