BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 4173155 · Received October 10, 2014

    Report

    Report Number
    2916596-2014-01719
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE APPROXIMATE AGE OF THE DEVICE IS THREE YEARS. A PORTION OF THE PERCUTANEOUS LEAD WAS RETURNED TO THE MFR FOR EVALUATION IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL 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 THE PT EXPERIENCED A RED HEART ALARM. THE PT WAS ASLEEP CONNECTED TO THE PT CABLE WHEN THE ALARMS PRESENTED. THE PT WAS INSTRUCTED TO PLACE SELF ON BATTERY POWER. SUDDEN PUMP STOPPAGES CONTINUED TO OCCUR. THE LOG FILE INDICATED SEVERAL LOW SPEED/LOW FLOW EVENTS INCLUDING PUMP STOPS EVENTS. THE EVENTS OCCURRED WHILE CONNECTED TO A POWER MODULE PT CABLE ONLY. EVALUATION OF THE PERCUTANEOUS LEAD SHOWED DAMAGE TO THE LEAD AND A PERCUTANEOUS LEAD REPAIR WAS PERFORMED. THE REPAIR WAS NOT SUCCESSFUL. THE ORANGE WIRE FAILED. A MODIFIED PT CABLE WAS REQUESTED AND SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643310 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 105350

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male