BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2030980 · Received March 22, 2011

    Report

    Report Number
    2916596-2011-00121
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 26, 2011
    Report Date
    February 26, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT EXPERIENCED LOW FLOW ALARMS. THE LOW FLOW ALARMS TURNED INTO INTERMITTENT PUMP STOPPAGES AND RED HEART ALARMS. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ALARMS CONTINUED. A DECISION WAS MADE BY THE SURGEON TO EXCHANGE THE PATIENT'S LVAD. THE PATIENT REMAINS ONGOING ON THE NEW LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 98461

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention