BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3161765 · Received June 6, 2013

    Report

    Report Number
    2916596-2013-00707
    Event Type
    Death
    Date Received
    June 6, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 8, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WILL NOT BE RETURNING TO THE MANUFACTURER FOR EVALUATION, AS THE PUMP WAS NOT EXPLANTED FROM THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 10 MONTHS POST IMPLANT, THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS FOUND "FOAMING AT THE MOUTH" BY HIS WIFE. IT WAS REPORTED THAT THE LVAD WAS "WORKING FINE". NO ADDITIONAL INFORMATION WAS PROVIDED AND NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249673 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 115176

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death