BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAD, STERILE, CLINICAL

    MDR report key: 2413179 · Received January 10, 2012

    Report

    Report Number
    2916596-2012-00005
    Event Type
    Injury
    Date Received
    January 10, 2012
    Date of Event
    August 18, 2011
    Report Date
    December 15, 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 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 PT WAS IMPLANTED WITH A RIGHT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR THE PT ALLEGEDLY HAD POSITIVE BLOOD CULTURES AND THROMBUS STARTED TO FORM INSIDE THE PUMP. THE PUMP WAS SWABBED AND CAME BACK POSITIVE. THE PT RECEIVED A PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAD, STERILE, CLINICAL LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP 14086-2550-000 100225

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention