BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4100640 · Received September 17, 2014

    Report

    Report Number
    2916596-2014-01622
    Event Type
    Death
    Date Received
    September 17, 2014
    Date of Event
    July 15, 2014
    Report Date
    August 18, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S "AGE AT THE TIME OF THE EVENT", "DATE OF BIRTH", "GENDER", AND "WEIGHT" WERE NOT PROVIDED. THE PUMP WAS NOT RETURNED TO THE MFR FOR EVALUATION, AS IT WAS NOT EXPLANTED. 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 (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPIRED ON (B)(6) 2014 WHILE AT THE REHABILITATION CTR DUE TO EXCESSIVE GI BLEEDING. THE PT WAS BEING TRANSFUSED WITH BLOOD BUT THE GI BLEED COULD NOT BE CONTROLLED. A DECISION WAS MADE TO WITHDRAW SUPPORT. THE VAD COORDINATOR REPORTED THAT THE DEATH WAS NOT DEVICE RELATED AND THE PUMP WAS FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574940 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 137628

    Patients

    Seq Age Sex Outcome Treatment
    1 Death