BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3256854 · Received July 29, 2013

    Report

    Report Number
    2916596-2013-00963
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 WAS EXPERIENCING CHANGES IN THE PUMP SPEED. THE PATIENT STATED THAT HE EXPERIENCED 2 PUMP ALARMS OCCURRING THE PREVIOUS EVENING. ON INTERROGATION, "IT" WAS FOUND TO HAVE MULTIPLE LOW FLOWS WITH ASSOCIATED SPEED REDUCTIONS. THE RECORDED SPEEDS WERE RPMS OF 8800, 6970, 1720, 1580, AND 0 WITH ASSOCIATED LOW POWERS. THE EVENTS OCCURRED WHEN THE PATIENT WAS CONNECTED TO THE POWER MODULE. THE SYSTEM CONTROLLER AND PATIENT CABLE WERE REPLACED. THE PATIENT EXPERIENCED ANOTHER PUMP STOPPAGE. THE PATIENT WAS ASYMPTOMATIC. A DECISION WAS MADE TO EXCHANGE THE PATIENT'S PUMP. THE PATIENT REMAINS ONGOING WITH THE NEW LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354122 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 115176

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention