BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2141133 · Received June 22, 2011

    Report

    Report Number
    2916596-2011-00258
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN USE SUPPORTING THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION 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'S FLOWS AND PUMP POWER WERE BOTH HIGH AND A PUMP EXCHANGE WAS PLANNED. PER ADD'L INFO FROM THE PHYSICIAN, THE PT PRESENTED WITH MASSIVE LEFT VENTRICLE (LV) AND RIGHT VENTRICLE (RV) DILATION. THE PT HAD MILD TO MODERATE AORTIC INSUFFICIENCY (AI). IT WAS LATER NOTED FROM THE TRANSESOPHAGEAL ECHO IN THE OPERATING ROOM, THAT THE AORTIC VALVE WAS CLOSED. THE AORTIC INSUFFICIENCY WAS REPAIRED. NO PUMP EXCHANGE WAS NEEDED. THE PT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 94494

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention