BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4213153 · Received August 4, 2014

    Report

    Report Number
    2916596-2014-01333
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 7, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND WAS DISCHARGED HOME WITHOUT ANY ISSUES AND NO FURTHER PROBLEMS HAVE BEEN REPORTED. A PORTION OF THE PERCUTANEOUS LEAD THAT WAS REMOVED DURING THE REPAIR 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 PERFUSIONIST THAT THE PATIENT CAME INTO THE OUTPATIENT VAD CLINIC WITH COMPLAINTS OF A BRIEF RD HEART ALARM. THE PATIENT REPORTED THAT SHE THOUGHT SHE WAS ON BATTERY AT THE TIME OF THE ALARM. THE SYSTEM CONTROLLER WAS EXCHANGED WITH ANOTHER SYSTEM CONTROLLER. THE FOLLOWING DAY SHE CAME INTO THE OUTPATIENT VAD CLINIC AND UPON INSPECTION OF THE DATA LOG, SEVERAL PUMP STOP ALARMS WITH SPEED WELL BELOW HER LOW SPEED SET LIMIT WERE CONFIRMED. THE LOG SUGGESTED THAT SHE WAS CONNECTED TO THE POWER MODULE AT THE TIME OF THE EVENTS. REVIEW OF THE INTERNAL X-RAY APPEARED UNREMARKABLE WITH THE EXTERNAL X-RAY CONTAINING A SMALL KINK APPROXIMATELY 4 TO 6 INCHES FROM THE EXIT SITE. THE MANUFACTURER PERFORMED A PERCUTANEOUS LEAD DISTAL END REPLACEMENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455619 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 113699

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention