BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 4102282 · Received September 17, 2014

    Report

    Report Number
    2916596-2014-01537
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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. THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC WITH MULTIPLE EPISODES OF "NO EXTERNAL POWER" ALARMS OCCURRING MOST NIGHTS. THE PATIENT DENIES HEARING AUDIBLE ALARMS AT THOSE TIMES BEYOND INFREQUENT LOW BATTERY ALERTS THAT RESOLVED AS SOON THE BATTERIES WERE CHANGED. THERE WAS NO VISIBLE DAMAGE TO THE DRIVELINE OR CONTROLLER. THE PATIENT RECEIVED A NEW BACK UP CONTROLLER WHILE IN THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577128 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106762 137957

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR