BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3628809 · Received January 29, 2014

    Report

    Report Number
    2916596-2014-00102
    Event Type
    Injury
    Date Received
    January 29, 2014
    Date of Event
    December 30, 2013
    Report Date
    December 31, 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 MFR 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT UNDERWENT A PUMP EXCHANGE FROM ONE LVAD TO ANOTHER LVAD DUE TO HEMOLYSIS. IT WAS ALSO REPORTED THAT OVER THE LAST SEVERAL WEEKS THE PATIENT HAS BEEN HAVING INCREASING LACTATE DEHYDROGENASE (LDH) AND PFH LEVELS. LDH TODAY APPROXIMATELY 2200, PFH 50 (DOWN FROM 90 LAST WEEK). PATIENT WITHOUT COMPLAINTS. NO URINE CHANGES OR INCREASED IN HEART FAILURE SYMPTOMS. H/H SLIGHT DROP TODAY. PER HEMATOLOGY, PATIENT STARTED ON ARIXTRA AND WILL SEE HEMATOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63819 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 117496

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention