BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3011144 · Received March 15, 2013

    Report

    Report Number
    2916596-2013-00280
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 18, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 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). APPROXIMATELY 13 MONTHS POST IMPLANT THE VAD COORDINATOR REPORTED THAT THE PT HAD DEVELOPED HEMOLYSIS. THE PT WAS HOSPITALIZED AND UPGRADED TO 1A STATUS ON THE HEART TRANSPLANT LIST. HIS LACTATE DEHYDROGENASE (LDH) WAS 1358, PLASMA FREE HEMOGLOBIN (PFHGB) WAS 24, AND HIS HAPTOGLOBIN WAS LESS THAN 10. THE PT ALSO REPORTEDLY EXPERIENCED BOUTS OF NAUSEA AND VOMITING DURING HIS ADMISSION. THE PT UNDERWENT A HEART TRANSPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110852 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 109870

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R