BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3111338 · Received May 9, 2013

    Report

    Report Number
    2916596-2013-00542
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 11, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR HEMOLYSIS. HIS LACTATE DEHYDROGENASE (LDH) WAS 1900, AND THEN DECREASED TO 500. THE HOSPITAL STAFF DETERMINED THAT THE PATIENT'S LEFT VENTRICLE (LV) NEEDS TO BE FULL OF VOLUME. THE PATIENT WAS MONITORED AND HIS SPEED WAS ADJUSTED. THE PATIENT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202671 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 105903 114594

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention