BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2431144 · Received January 25, 2012

    Report

    Report Number
    2916596-2012-00106
    Event Type
    Injury
    Date Received
    January 25, 2012
    Date of Event
    December 27, 2011
    Report Date
    December 29, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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). THE VAD COORDINATOR REPORTED THAT AFTER 3 MONTHS OF SUPPORT, THE PATIENT PRESENTED WITH INCREASING LDH, HEMATURIA AND REDUCED PUMP FLOWS. THE HOSPITAL SUSPECTED THROMBUS IN THE DEVICE AND WHILE THE PATIENT WAS BEING EVALUATED FOR THROMBUS, IT WAS DETERMINED THAT THE PATIENT WAS A CANDIDATE FOR RECOVERY. THE DEVICE WAS EXPLANTED DUE TO SUSPECTED THROMBUS AND THE PATIENT IS BEING SUPPORTED BY THE NATIVE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 108888

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention