BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3082472 · Received April 25, 2013

    Report

    Report Number
    2916596-2013-00494
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. 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 MANUFACTURER'S DEVICE TRACKING SYSTEM THAT THE PATIENT UNDERWENT A PUMP EXCHANGE FROM ONE LVAD TO ANOTHER LVAD DUE TO SUSPECTED THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179747 HEARTMATE II LVAD DSQ: LEFT VENTRIOCULAR ASSIST DEVICE DSQ THORATEC CORP. 1049911 120916

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention