BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2885006 · Received December 19, 2012

    Report

    Report Number
    2916596-2012-01238
    Event Type
    Death
    Date Received
    December 19, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 27, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VAD COORDINATOR REPORTED THAT THE HOSPITAL WILL NOT BE RETURNING ANY OF THE PT'S EQUIPMENT TO THE MFR FOR ANALYSIS. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS FOUND DOWN WITH BOTH BATTERIES DISCONNECTED. THE PARAMEDICS RECONNECTED THE BATTERIES AND TRANSPORTED THE PT TO THE NEAREST EMERGENCY ROOM., THEN TO THE IMPLANTING HOSPITAL WHERE HE LATER EXPIRED. THE HOSPITAL WAS NOT AWARE HOW LONG THE PT HAD BEEN WITHOUT POWER TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 84778

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death