BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTRICULAR ASSIST DEVICE

    MDR report key: 2470664 · Received February 24, 2012

    Report

    Report Number
    2916596-2012-00179
    Event Type
    Death
    Date Received
    February 24, 2012
    Date of Event
    June 15, 2011
    Report Date
    January 27, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISPOSED BY THE HOSP. 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 VENTRICULAR ASSIST DEVICE. THE VAD COORD REPORTED THAT THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRICULAR ASSIST DEVICE DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 85398

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death