BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 4173137 · Received October 10, 2014

    Report

    Report Number
    2916596-2014-01717
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE APPROXIMATE AGE OF THE DEVICE IS 14 MONTHS. A PORTION OF THE PERCUTANEOUS LEAD WAS RETURNED TO THE MFR FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. 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. THE VAD COORDINATOR REPORTED THAT THE PT EXPERIENCED PUMP STOPS WITH A RED HEART ALARM WHILE IN THE BATHROOM. THE ALARMS STOPPED AS THE PT RETURNED TO BED. IT WAS NOTED THAT EVENT ONLY OCCURRED WHEN CONNECTED TO THE POWER MODULE. THE PT STATED SHE FELT A HEADACHE COME ON WHEN THE PUMP SLOWED OR STOPPED. A REVIEW OF THE X-RAY IMAGES WAS INCONCLUSIVE. THE CUSTOMER REPORTS THAT PT EXPERIENCED NO ALARMS WHILE ON BATTERIES. A REVIEW OF LOG FILE REVEALED TWO INSTANCES OF RED HEART ALARMS WHERE THE PUMP WAS UNABLE TO MAINTAIN THE SET SPEED WITH THE MOTOR STOPPING, AN INCREASE IN POWER, AND A YELLOW WRENCH/REPLACE CONTROLLER ALARM WHILE CONNECTED TO THE POWER MODULE. A PERCUTANEOUS LEAD REPAIR WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643076 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 127928

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female