BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2800939 · Received October 18, 2012

    Report

    Report Number
    2916596-2012-00993
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON GOING WITH THE IMPLANTED DEVICE. 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. THE CARDIOLOGIST REPORTED THAT THE PT HAD BEEN ADMITTED FOR SUSPECTED FLOW OBSTRUCTION. AN ECHO WAS PERFORMED SHOWING THAT THE LEFT VENTRICLE WAS DISTENDED, AND A GRINDING SOUND WAS HEARD IN THE PUMP. PT WAS STARTED ON MEDICATION AND THEIR CONDITION IMPROVED.

    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. 104911 114714

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention