BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2930391 · Received January 22, 2013

    Report

    Report Number
    2916596-2013-00079
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 24, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE ADD'L INFO FROM THE HOSPITAL REGARDING THIS EVENT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR'S OFFICE ASSIST REPORTED THAT THE PT HAD BEEN READMITTED TO THE HOSPITAL FOR HEMOLYSIS. NO OTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29683 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 103748

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization