BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2921752 · Received January 16, 2013

    Report

    Report Number
    2916596-2013-00054
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 19, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENT REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS TRANSPLANTED. THE HOSPITAL WOULD LIKE THE PUMP EVALUATED TO CHECK FOR THROMBUS DUE TO INTERMITTENT POWER SPIKES AND HEMOLYSIS. ADDITIONAL INFORMATION SUBMITTED TO THE MANUFACTURER REPORTED THAT THE PATIENT WAS UPGRADED TO 1A STATUS. THE PATIENT HAD TROUBLE WITH BOTH CLOTTING PUMPS AND FREQUENT GASTROINTESTINAL (GI) BLEEDING. THE PATIENT RECEIVED LARGE AMOUNTS OF BLOOD TO BALANCE THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24177 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 112782

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention