BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3924940 · Received June 18, 2014

    Report

    Report Number
    2916596-2014-00994
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WAS ADVISED THAT THE LVAD PUMP WILL NOT BE RETURNING FOR EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION THE PUMP WAS NOT RETURNED. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT OF INTRACEREBRAL HEMORRHAGING COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE LISTS BLEEDING AND STROKE AS POSSIBLE ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). A DEVICE TRACKING FORM WAS RECEIVED BY THE MFR WHICH INDICATED THAT THE PT EXPIRED WITH THE CAUSE OF EXPIRATION BEING "INTRACEREBRAL HEMORRHAGE". NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356738 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 111701

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death