BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3950542 · Received July 11, 2014

    Report

    Report Number
    2916596-2014-01166
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AGE OF THE PATIENT WAS NOT PROVIDED TO THE MANUFACTURER. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED GI BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. THE PATIENT REMAINS ONGOING ON VAD SUPPORT. THE INSTRUCTIONS FOR USE (IFU) LISTS BLEEDING AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT CONTINUES ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED. 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT AFTER APPROXIMATELY 9 1/2 MONTHS OF SUPPORT OF THE LVAD, THE PATIENT WAS READMITTED FOR GASTROINTESTINAL (GI) BLEEDING AND RECEIVED A TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406888 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 130912

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention