BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4100723 · Received September 12, 2014

    Report

    Report Number
    2916596-2014-01608
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 15, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). INFORMATION WAS PROVIDE TO THE MANUFACTURER THROUGH THEIR DEVICE TRACKING SYSTEM INDICATING THAT A PUMP EXCHANGE TOOK PLACE ON (B)(6) 2014. THE REASON FOR EXCHANGE IS NOTED AS PUMP THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565067 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 103442

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention NA.