BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3965033 · Received July 17, 2014

    Report

    Report Number
    2916596-2014-01214
    Event Type
    Death
    Date Received
    July 17, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 18, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR, AND IS CURRENTLY BEING ANALYZED. 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 (LVAD). APPROXIMATELY 2 MONTHS POST-IMPLANT OF (B)(4) IT WAS REPORTED THAT THE PT HAD A SUBARACHNOID HEMORRHAGE (SAH) AND ANTICOAGULATION WAS STOPPED. AN INCREASE IN PUMP POWER WAS SEEN AND THE PT HAD HEMOLYSIS AND AN INCREASE IN LDH. THE PT WAS TAKEN TO THE OPERATING ROOM AND THE PUMP WAS EXPLANTED AND AN EXTRACORPOREAL WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418012 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911JPN 133972

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention| D NA.