BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC IVAD

    MDR report key: 3013650 · Received March 20, 2013

    Report

    Report Number
    3013650
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    September 24, 2008
    Report Date
    March 20, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED TO HOSPITAL FOR EXCHANGE OF THORATEC TLC-11 DRIVERS. EACH DRIVER WAS PLACED ON PATIENT AND RAN FOR SEVERAL HOURS, WITHOUT COMPLICATION. PATIENT WILL BE DISCHARGED (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115550 THORATEC IVAD LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1