BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3951930 · Received July 7, 2014

    Report

    Report Number
    2916596-2014-00982
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING 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 HOSP REPORTED THE PT HAD A RIGHT SIDED INFARCTION, EXHIBITING SYMPTOMS. LEFT SIDED WEAKNESS, SLURRED SPEECH. THE PT WAS ADMINISTERED MEDICATION. NO ADVERSE EVENTS WERE CAPTURED IN THE LOG FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394896 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVCE DSQ THORATEC CORP. 104911 118686

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention