BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2941605 · Received January 29, 2013

    Report

    Report Number
    2916596-2013-00114
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 2, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS SUCCESSFULLY EXCHANGED AND THE PATIENT REMAINS ONGOING ON LVAD SUPPORT WITHOUT ANY FURTHER ISSUE REPORTED. THE USER FACILITY REPORT # (B)(4) WAS RECEIVED FROM THE (B)(6) REGISTRY. THE EXPLANTED PUMP 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 MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO POWER ELEVATIONS AND INTERMITTENT PUMP STOPPAGES. THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE OPERATING ROOM (OR) AND THE PUMP WAS EXCHANGED WITH ANOTHER LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38471 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 86168

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention