BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3123656 · Received May 15, 2013

    Report

    Report Number
    2916596-2013-00545
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 16, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVAL AND IS CURRENTLY BEING ANALYZED. THE ATTACHED USER FACILITY REPORT# (B)(4) WAS RECEIVED FROM THE (B)(6) REGISTRY. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT AFTER 2 MONTHS OF SUPPORT ON THE LVAD, THE PT WAS READMITTED DUE TO ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS AND DARK URINE. THE PT WAS GIVEN TISSUE PLASMINOGEN ACTIVATOR (TPA) AND THE LDH LEVEL DECREASED. THE PT REMAINED HOSPITALIZED FOR HEMOLYSIS AND RECEIVED A PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214485 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 121705

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention