BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1812348 · Received August 17, 2010

    Report

    Report Number
    2916596-2010-00210
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    May 28, 2010
    Report Date
    July 19, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO CONCLUSIVELY DETERMINE THE REPORTED EVENT OF HEMOLYSIS AS THE DEVICE WAS DISPOSED OF AND WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT'S LVAD WAS EXCHANGED DUE TO THE PATIENT HAVING HEMOLYSIS. THE PATIENT REMAINS ONGOING ON THE NEW LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 74332

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention