BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3834504 · Received May 2, 2014

    Report

    Report Number
    2916596-2014-00697
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 30, 2014
    Report Date
    April 4, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR TREATMENT OF A GI BLEED. A COLONOSCOPY WAS PERFORMED AND THE SOURCE OF THE BLEED WAS CLIPPED. THE PUMP SPEED WAS ALSO LOWERED. THE PATIENT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264066 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 106015 132520

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention