BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3760674 · Received April 8, 2014

    Report

    Report Number
    2916596-2014-00536
    Event Type
    Death
    Date Received
    April 8, 2014
    Date of Event
    February 9, 2014
    Report Date
    March 11, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS ADVISED THAT THE LVAD PUMP WAS NOT EXPLANTED FROM THE PATIENT, THEREFORE, WILL NOT BE RETURNING FOR EVALUATION. 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). IT WAS REPORTED BY THE BIO-MED THAT THE PATIENT EXPIRED POSSIBLY DUE TO INFECTION AT THE PERCUTANEOUS LEAD EXIT SITE ASSOCIATED WITH BACTEREMIA WHICH MAY HAVE CONTRIBUTED TO PATIENT'S DEATH ON (B)(6) 2014, WHILE ON HOSPICE. NO AUTOPSY WAS PERFORMED. THE CARE PROVIDERS ARE REPORTED TO SUSPECT THE POSSIBLE INFECTION ISSUE/RELATION. LOG FILES WERE NOT SUBMITTED AND THE SYSTEM CONTROLLER WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. THE LVAD PUMP WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210418 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 93869

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death