BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRICULAR ASSIST DEVICE

    MDR report key: 1980238 · Received February 2, 2011

    Report

    Report Number
    2916596-2011-00052
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. NO FURTHER INFO 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 VAD COORDINATOR REPORTED THAT AN EXCESSIVE FIBRIN FORMATION WAS FOUND IN THE PUMP AND INFLOW CANNULA. A PUMP EXCHANGE WAS COMPLETED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRICULAR ASSIST DEVICE VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 85396

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention