BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2781404 · Received October 10, 2012

    Report

    Report Number
    2781404
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 8, 2012
    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

    LOOSE CONNECTION OF DRIVELINE THAT DIRECTLY CONNECTS TO THE SYSTEM CONTROL. CHEST X-RAY WAS DONE, BUT DID NOT SHOW ANY INTERNAL DEVICE MALFUNCTION. (B)(6) (TECHNICAL SUPPORT SPECIALIST) FROM THORATEC REINFORCED CONNECTION WITH STEEL FASTERNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1