BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2875038 · Received December 12, 2012

    Report

    Report Number
    2916596-2012-01166
    Event Type
    Death
    Date Received
    December 12, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 13, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT EXPIRED. 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. THE VAD COORDINATOR REPORTED THAT THE PT WAS FOUND DEAD BY FAMILY MEMBER AFTER A FEW HOURS OF NOT BEING ABLE TO CONTACT THE PT. THE PT'S BATTERIES WERE EMPTY, AND IT IS UNCLEAR EXACTLY WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 101799

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death