BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3862730 · Received May 22, 2014

    Report

    Report Number
    2916596-2014-00812
    Event Type
    Death
    Date Received
    May 22, 2014
    Date of Event
    April 25, 2013
    Report Date
    April 22, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT EXPIRED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. AN OUTCOME OF DEATH WAS REPORTED VIA DEVICE TRACKING FORM, WHICH NOTED THE CAUSE OF EXPIRATION AS "ISCHEMIC BOWEL/SEPSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306701 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 122480

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death