BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC CORP

    MDR report key: 4115841 · Received September 18, 2014

    Report

    Report Number
    2916596-2014-01664
    Event Type
    Death
    Date Received
    September 18, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 10, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BACKGROUND: ON (B)(6) 2013, HEARTMATE II LVAD IMPLANTATION FOR DT INDICATION. ON (B)(6) 2014, LVAD PUMP STOP ALARMS NOTED DURING ROUTINE INTERROGATION. KUB WAS NEGATIVE FOR SHIELDING DAMAGES. PM AND CONTROLLER CHANGED OUT PER THORATEC RECOMMENDATIONS. ON (B)(6) 2014, TWO MORE PUMP STOP ALARMS RECORDED ON (B)(6). DRIVELINE TESTING AND CONTROLLER INTERROGATION BY (B)(4) FROM THORATEC CONCLUDED THAT THERE WAS LIKELY A DRIVELINE SHORT. ON (B)(6) 2014, EXTERNAL DRIVELINE REPLACED BY (B)(4) WITHOUT COMPLICATIONS. NO RECURRENT ALARM AFTER THE REPAIR. ON (B)(6) 2014, LVAD INTERROGATION SHOWED NO PUMP RECURRENT PUMP STOP ALARMS. NO RED HEART ALARMS. ON (B)(6) 2014, PT DIED. FINDINGS: THE EPC CONTROLLER HAS TWO FULLY REDUNDANT ELECTRICAL SYSTEMS. BOTH FUSES IN THE CONTROLLER WERE 'BLOWN' D/T A BREAK IN THE DRIVELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579293 THORATEC CORP HEARTMATE II LVAD 53941 AND SYSTEM CONT DSQ THORATEC CORP. UNIFY CD 3231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death BIVENTRICULAR ICD: MODEL UNIFY CD 3231-40