BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2834385 · Received November 15, 2012

    Report

    Report Number
    2834385
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    June 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT AWAKENED FROM SLEEP (B)(6) 2012 WHILE ON POWER-BASED UNIT WITH MULTIPLE ALARMS, RED HEART DISPLAY ON HM II CONTROLLER. REVIEW HISTORY ON VAD- NUMEROUS EPISODESLOW-SPEED OPERATION WITH PUMP STOPPAGE APPROXIMATELY X17. EXTERNAL DRIVELINE REPAIR (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1