BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3032468 · Received March 29, 2013

    Report

    Report Number
    2916596-2013-00346
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 1, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS HAVING RIGHT-SIDED HEART FAILURE SYMPTOMS AND NEEDED A RIGHT SIDE SUPPORT DEVICE. THE PT HAD BEEN RUNNING AT 10,000 RPM AND THE AORTIC VALVE WAS STILL OPENING. A RAMP STUDY WAS PERFORMED AND THE AORTIC VALVE CONTINUED TO OPEN WITH INCREASES IN RPM'S. THE SURGEON SUSPECTED POSSIBLE PUMP THROMBUS. THE PT'S PUMP WAS EXPLANTED AND THE PT RECEIVED AN ARTIFICIAL HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130169 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114710

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention