BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3142675 · Received May 30, 2013

    Report

    Report Number
    2916596-2013-00648
    Event Type
    Death
    Date Received
    May 30, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 3, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE USER FACILITY REPORT # (B)(4) WAS RECEIVED FROM THE INTERMACS REGISTRY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED. (B)(4)

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT EXPERIENCED POWER SPIKES FOR A PERIOD OF TIME. THE PT HAD ONGOING GI BLEEDING. THE PT HAD ANA ACUTE EPISODE OF HEMOLYSIS AND RENAL FAILURE REQUIRING DIALYSIS, WHICH BEGAN THE DAY OF THE ADMISSION TO THE HOSPITAL. DIALYSIS WAS PROVIDED, BUT THE PT DECOMPENSATED AND THE FAMILY WITHDREW SUPPORT. THE PT WAS ALSO REPORTED TO HAVE EXPERIENCED SEVERAL MINOR STROKES BEFORE HIS EXPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238980 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 95666

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death