BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2771874 · Received October 2, 2012

    Report

    Report Number
    2916596-2012-00929
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    September 8, 2012
    Report Date
    September 8, 2012
    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 PUMP WAS RETURNED TO THE MFR, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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 HAD BLOODY URINE AND WAS EXPERIENCING INTERMITTENT POWER ELEVATIONS (ABOVE 10 WATTS). THE PT WAS TAKEN BACK TO THE OPERATING ROOM THAT DAY, AND HIS PUMP WAS EXCHANGED. THE PT REMAINS ONGOING WITH THE NEW LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114087

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention