BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3922197 · Received May 23, 2014

    Report

    Report Number
    2916596-2014-00810
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS STILL IN USE SUPPORTING THE PATIENT; HOWEVER, THE REPLACED PORTION OF THE PERCUTANEOUS LEAD WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT EXPERIENCED ALARMS WHILE CONNECTED TO THE POWER MODULE AND PUMP STOPPAGE. IT WAS ALSO REPORTED BY THE PATIENT WHILE SHE WAS IN THE CLINIC THAT THE PUMP WAS SPUTTERING. IT WAS REPEATED WHEN SHE WAS ATTACHED TO A DIFFERENT POWER MODULE. THE PATIENT WAS PLACED ON BATTERY POWER. THE VAD COORDINATOR REPORTED THAT RED HEART ALARMS WERE PRODUCED WHEN THE PERCUTANEOUS LEAD WAS MANIPULATED NEAR THE DISTAL END BEND RELIEF, WHILE BOTH POWER LEADS OF THE SYSTEM CONTROLLER WERE CONNECTED TO BATTERIES. THE PERCUTANEOUS LEAD WAS EVALUATED AND DAMAGE TO PERCUTANEOUS LEAD WAS FOUND. A PORTION OF THE DISTAL END OF THE PERCUTANEOUS LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307320 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 117874

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other