BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYS CONTROLLER

    MDR report key: 3952569 · Received May 15, 2014

    Report

    Report Number
    0002916596-2014-00768
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    January 6, 2014
    Report Date
    April 15, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYS CONTROLLER WAS RETURNED TO THE MFR FOR EVALUATION. DURING INITIAL ANALYSIS OF THE CONTROLLER, THE EXTERNAL BACKUP BATTERY (EBB) PREVENTED A TEST PUMP FROM OPERATING WHEN BOTH POWER CABLES WERE DISCONNECTED AND THE SYS CONTROLLER DID NOT ALARM. THE MFR IS CURRENTLY UNDERGOING ADDITIONAL ANALYSIS ON THE SYS CONTROLLER. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 3 MONTHS POST-IMPLANT, IT WAS REPORTED THAT DURING THE CHARGE OF THE INTERNAL BATTERY ON THE PT'S SYS CONTROLLER, A DRIVELINE DISCONNECTED ALARM APPEARED WHEN CONNECTED TO ONE POWER SOURCE. THE SYS CONTROLLER WAS CONNECTED TO TEST EQUIPMENT AND THE CONTROLLER FUNCTIONED PROPERLY; HOWEVER, WHEN BOTH POWER SOURCES WERE DISCONNECTED, THE CONTROLLER WENT INTO SLEEP MODE. A SECOND ATTEMPT TO CHARGE THE INTERNAL BATTERY WHILE CONNECTED TO ONE POWER SOURCE WAS MADE AND THE SAME DRIVELINE DISCONNECTED ALARM APPEARED. THE SYS CONTROLLER WAS EXCHANGED AND NO EFFECTS TO THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290834 HEARTMATE II SYS CONTROLLER LVAD SYS CONTROLLER DSQ THORATEC CORP. 106017 130237

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other