BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2894200 · Received December 27, 2012

    Report

    Report Number
    2916596-2012-01267
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    March 20, 2012
    Report Date
    December 4, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE ADD'L INFO REGARDING THE EVENT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED. THE ATTACHED USER FACILITY REPORT WAS REC'D FROM THE (B)(6).

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR REC'D A USER FACILITY REPORT REC'D FROM THE (B)(6) WHICH STATED: "PT HAD ECHOCARDIOGRAM WHILE IN THE HOSPITAL TO INVESTIGATE ELEVATED PLASMA FREE HEMOGLOBIN AND LACTATE DEHYDROGENASE. FOUND CLOT WAS IN DEVICE." THE PT WAS TRANSFERRED TO INTENSIVE CARE FOR TISSUE PLASMINOGEN ACTIVATOR PROTOCOL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 96334

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention