BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3082474 · Received April 25, 2013

    Report

    Report Number
    2916596-2013-00489
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 27, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. 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). THE VAD COORDINATOR REPORTED THAT THE PATIENT HAD HEMOLYSIS. A RAMP STUDY WAS PERFORMED AND SHOWED THAT THE LEFT VENTRICLE WAS NOT UNLOADING. PATIENT WAS TRANSPLANTED. UPON EXAMINATION OF PUMP AT TRANSPLANT, PUMP THROMBUS WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180182 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 117873

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention