BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2838268 · Received November 7, 2012

    Report

    Report Number
    2916596-2012-01093
    Event Type
    Death
    Date Received
    November 7, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR, 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPIRED, AND THE PRIMARY CAUSE OF DEATH WAS BRAIN STEM INFARCTION. IT WAS REPORTED THAT SINCE THE PUMP WAS IMPLANTED, THE PT'S COURSE HAS BEEN COMPLICATED. HE HAS HAD ALTERED MENTAL STATUS WITH A NEGATIVE CT SCAN, EEG, AND CTA OF THE HEAD AND NECK. THE PT WAS DIAGNOSED WITH A RIGHT INTERNAL JUGULAR AND CEPHALIC ACUTE THROMBUS. HE DEVELOPED FEVERS AS HIGH AS 108 DEGREES, WITH NO EVIDENCE OF AN INFECTIOUS PROCESS OR INTRA-ABDOMINAL CAUSE. HE ALSO DEVELOPED TRANSAMINITIS, THOUGHT TO BE SHOCK LIVER AND AN ACUTE KIDNEY INJURY. NEUROLOGY, INFECTIOUS DISEASE, NEPHROLOGY, GASTROENTEROLOGY, AND GENERAL SURGERY WERE ALL CONSULTED REGARDING THE CARE OF THIS PT. HIS HEPATIC AND RENAL FUNCTION RECOVERED FULLY; HOWEVER, THE PT REMAINED IN AN UNRESPONSIVE STATUS DESPITE MAXIMAL MEDICAL SUPPORT. THE PT DEVELOPED A GI BLEED AND AFTER A PROLONGED COURSE AND DISCUSSION WITH THE FAMILY A DECISION WAS MADE THAT THE PT'S CARE WOULD BE MADE COMFORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 116727

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death