BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE LVAD

    MDR report key: 3152482 · Received June 5, 2013

    Report

    Report Number
    2916596-2013-00706
    Event Type
    Death
    Date Received
    June 5, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 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 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT EXPIRED. THE PATIENT WAS CODED AND PLACED ON CONTINUOUS VENO-VENOUS HAEMODIAFILTRATION (CVVHD). THE PATIENT WAS GIVEN FULL INTROPIC SUPPORT. NO ALARMS WERE REPORTED OR PROBLEMS WITH THE PUMP. THE PATIENT LIKELY EXPIRED DUE TO SEPTIC SHOCK. RV FAILURE LEADING TO MULTI-SYSTEM ORGAN FAILURE (MSOF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248385 HEARTMATE LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 124415

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death