BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3072364 · Received April 19, 2013

    Report

    Report Number
    2916596-2013-00427
    Event Type
    Injury
    Date Received
    April 19, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE AND TWO SYSTEM CONTROLLERS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AND ARE CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MANUFACTURER RECEIVED A REPORT THROUGH DEVICE TRACKING INDICATING THAT, AFTER THREE MONTHS OF SUPPORT, THE HOSPITAL EXCHANGED THE PATIENT'S PUMP WITH ANOTHER LVAD DUE TO PUMP THROMBOSIS. ADDITIONAL INFORMATION PROVIDED BY THE VAD COORDINATOR INDICATED THAT THE PATIENT HAD BEEN EXPERIENCING INCREASED PLASMA HEMOGLOBIN AND ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS. SEVERAL DAYS BEFORE THE PUMP EXCHANGE, THE PATIENT RECEIVED A RED HEART ALARM THAT REPORTEDLY RESOLVED AFTER THE SYSTEM CONTROLLER WAS CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170746 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 120921

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention