BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3073029 · Received April 23, 2013

    Report

    Report Number
    3073029
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 19, 2013
    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

    UNREPAIRABLE DRIVELINE FRACTURE. PATIENT REPORTED LOW SPEED ALARMS AT HOME. ADMITTED AND FOUND TO HAVE A DRIVELINE FRACTURE THAT WAS CAUSING PUMP STOPPAGE WITH MANIPULATION OF THE DRIVELINE. DIAGNOSED VIA XRAY. PATIENT REQUIRED PUMP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174513 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1