BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 1700942 · Received May 26, 2010

    Report

    Report Number
    2916596-2010-00124
    Event Type
    Death
    Date Received
    May 26, 2010
    Date of Event
    April 22, 2010
    Report Date
    April 27, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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). THE VAD COORD REPORTED THAT THE PT HAD COME INTO THE ER WITH COMPLAINTS OF SHORTNESS OF BREATH, DIZZINESS, AND WAS SLURRING HIS WORDS. HE WAS ADMITTED AND WAS PLACED ON PRIMACOR AND DIURESED. THE HEMODYNAMICS IMPROVED THE FOLLOWING DAY. HOWEVER, HE DEVELOPED RENAL INSUFFICIENCY OVER THE COURSE OF A FEW DAYS, AND HIS INR WENT FROM 2.4 TO 9 OVERNIGHT. THE PT BECAME HYPOXIC SUDDENLY AND WHILE BEING INTUBATED, WENT INTO VFIB. MULTIPLE ROUNDS OF DRUGS AND SHOCKS WERE INITIATED. HIS LDH AND PLASMA FREE HGB DID NOT SUGGEST PUMP CLOTS AND PUMP POWER WAS ALWAYS NORMAL. HOWEVER, THE PT UNFORTUNATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 77327

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death