BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2001462 · Received January 26, 2011

    Report

    Report Number
    2916596-2011-00037
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 30, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE CIRCULATORY SUPPORT SPECIALIST THAT WHILE THE PT WAS IN THE HOSPITAL FOR HIGH BLOOD SUGAR, HE EXPERIENCED RED HEART ALARMS. THE PT STATED THAT A "TINGLING" FEELING WAS FELT IN HIS CHEST AS IF THE PUMP WAS STOPPING. PER ADD'L INFO REC'D FROM THE VAD COORDINATOR WHEN THE PT EXPERIENCED A RED HEART ALARM, THE HOSPITAL STAFF NOTED THAT THE FLOW WAS 0. THE PUMP HAD STOPPED, AND THE SYSTEM CONTROLLER WAS EXCHANGED WITH THE PT'S BACKUP SYSTEM CONTROLLER. THE PT WAS ASYMPTOMATIC. LESS THAN 12 HRS LATER A RED HEART ALARM OCCURRED AGAIN AND THE FLOW WAS 0. THE SYSTEM CONTROLLER WAS EXCHANGED WITH A NEW SYSTEM CONTROLLER. X-RAYS WERE TAKEN OF THE DRIVELINE AND IT APPEARED INTACT. THE PT REMAINS ONGOING WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention