BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5621623 · Received April 29, 2016

    Report

    Report Number
    2916596-2016-00833
    Event Type
    Death
    Date Received
    April 29, 2016
    Date of Event
    March 24, 2016
    Report Date
    April 1, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 3 YEARS, 4 MONTHS. THE PUMP WAS NOT EXPLANTED AND THUS WAS NOT AVAILABLE FOR EVALUATION. STROKE IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2016 DUE TO A STROKE. PUMP PARAMETERS WERE REPORTEDLY STABLE DURING THE COURSE OF THE EVENT. THE PATIENT'S LACTATE DEHYDROGENASE LEVEL ALSO HAD BEEN STABLE AT APPROXIMATELY 300 U/L. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277451 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death