BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3003937 · Received March 12, 2013

    Report

    Report Number
    2916596-2013-00267
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENT 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 SURGEON REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH DARK URINE, ACUTE RENAL FAILURE, CREATININE 1.8, AND LACTATE DEHYDROGENASE (LDH) OF 10,000. THERE WERE NO POWER ELEVATIONS OR ALARMS. THE PUMP WAS EXCHANGED DUE TO SUSPECTED THROMBUS AND CLINICAL SIGNS OF HEMOLYSIS. THE HOSPITAL SUSPECTS THAT THE PUMP WAS NOT PERFORMING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103125 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 119462

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention