BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2092609 · Received May 4, 2011

    Report

    Report Number
    2916596-2011-00164
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. 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 SHOWING SIGNS OF PUMP THROMBUS. THE PUMP WAS SUCCESSFULLY EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 100931

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention