BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 2 LVAD

    MDR report key: 1002026 · Received February 25, 2008

    Report

    Report Number
    MW5005619
    Event Type
    Death
    Date Received
    February 25, 2008
    Date of Event
    December 7, 2007
    Report Date
    February 22, 2008
    Manufacturer
    THORATEC
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD INVESTIGATIONAL HEARTMATE 2 LVAD IMPLANTED. DEVICE APPEARED TO BE PULLING LARGE AMOUNTS OF AIR FROM SOMEWHERE AND WERE PASSED INTO THE PT. THE VENTS WERE UNABLE TO RID THE LARGE AMOUNTS OF AIR. AFTER MULTIPLE ATTEMPTS WERE MADE TO FIND WHERE THE AIR WAS COMING FROM AND ALLEVIATE THE POSSIBLE ENTRY SITES, THE DEVICE WAS CHANGED. A SECOND HEARTMATE 2 WAS IMPLANTED AND THE AIR EMBOLI PROBLEM CEASED. UNFORTUNATELY THE PT HAD A SEVERE NEUROLOGIC HIT DISPLAYED BY A GRAND MAL SEIZURE UNDER GENERAL ANESTHESIA. AFTER DISCUSSION WITH THE FAMILY, TREATMENT WAS WITHDRAWN THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE 2 LVAD DSQ THORATEC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death