BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2013381 · Received March 8, 2011

    Report

    Report Number
    2916596-2011-00099
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 7, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE 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 DEVICE ANALYSIS 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 DUE TO CHRONIC INFECTION, THE PATIENT'S LVAD PUMP WAS EXPLANTED. NO PUMP EXCHANGE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 77306

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention