BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3121610 · Received May 17, 2013

    Report

    Report Number
    2916596-2013-00607
    Event Type
    Death
    Date Received
    May 17, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MFR FOR EVAL AS IT WAS NOT EXPLANTED FROM THE PT. NO ADDITIONAL INFORMATION 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). APPROX 4 MONTHS POST IMPLANT, THE VAD COORDINATOR REPORTED THAT THE PT WAS FOUND UNRESPONSIVE IN HIS HOME. THERE WERE NO ALARMS REPORTEDLY COMING FROM THE DEVICE AT THE TIME THE PT WAS FOUND. EMERGENCY MEDICAL SERVICES WERE DISPATCHED AND THE PT WAS TRANSPORTED TO THE ICU. THE PT EXPIRED IN THE ICU. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218639 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 120267

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death