BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3780721 · Received April 22, 2014

    Report

    Report Number
    2916596-2014-00633
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 25, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT SUFFERED AN EMBOLIC STROKE. PUMP THROMBUS WAS SUSPECTED. THE PT HAS SIGNS AND SYMPTOMS OF HEMOLYSIS WITH ELEVATED LDH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243901 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 124864

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention