BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 3022564 · Received March 22, 2013

    Report

    Report Number
    2916596-2013-00312
    Event Type
    Death
    Date Received
    March 22, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 22, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. 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). THE VAD COORDINATOR REPORTED THAT THE PT EXPIRED. IT WAS NOTED THAT THE PT DIDN'T FOLLOW PROTOCOL CONNECTING BACK TO BATTERIES. PUMP WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119170 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 113481

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death