BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 11 SYSTEM CONTROLLER

    MDR report key: 3802200 · Received March 24, 2014

    Report

    Report Number
    2916596-2014-00408
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. 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 VAD COORDINATOR THAT THE PATIENT HAD AN ALARM COMING FROM HIS CONTROLLER. THE PATIENT'S WIFE STATES PATIENT HAD AUDIO ALARMS ON BATTERIES AND POWER MODULE. AUDIO ALARMS WOULD OCCUR INTERMITTENTLY. BROUGHT PATIENT INTO OFFICE, PUMP OFF, AND LOW SPEED OPERATIONS WERE OCCURRING. THE PATIENT STATES HE DID FEEL THE VIBRATION IN HIS CHEST. THE SYSTEM CONTROLLER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171335 HEARTMATE 11 SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103696 89108

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention