BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3052216 · Received April 9, 2013

    Report

    Report Number
    2916596-2013-00355
    Event Type
    Death
    Date Received
    April 9, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 11, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 EXPIRED FROM FUNGEMIA-FUNGAL INFECTION OF THE BLOOD STREAM, WHICH "SEEDED" THE PUMP. THE INFECTION COULD NOT BE CLEARED UNDER NORMAL IV ANTIFUNGAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144507 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 112479

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death