BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2093822 · Received April 6, 2011

    Report

    Report Number
    2916596-2011-00142
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED EVENT, AS THE DEVICE REMAINS IN USE SUPPORTING THE PATIENT WITHOUT FURTHER REPORTED ISSUES. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    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 GONE INTO THE CLINIC STATING THAT HE PASSED OUT 2 WEEKS PRIOR. THERE WERE NO PUMP ALARMS AT THE TIME OF THE EVENT AND 911 WAS CALLED. WHEN THE AMBULANCE ARRIVED THE PATIENT WAS ALERT, FELT FINE, AND HIS BLOOD SUGAR WAS FINE. THE PATIENT WAS NOT TAKEN TO THE HOSPITAL AND HE DID NOT NOTIFY THE ON CALL TEAM OF THE EVENT. THE PATIENT'S LOG FILE WAS REVIEWED AND IT DID NOT SHOW ANY ALARMS OR ISSUES. THE PATIENT CALLED THE VAD COORDINATOR THE FOLLOWING MORNING AND SAID HE HAD EXPERIENCED A RED HEART ALARM AND FOUND THAT HIS DRIVELINE BECAME DISCONNECTED. THE PATIENT GOT LIGHTHEADED BUT DID NOT PASS OUT. ONCE THE DRIVELINE WAS CONNECTED THE PATIENT WAS FINE. A FEW HOURS LATER, THE PUMP ALARMED WITH AN INTERMITTENT BEEP FOR A COUPLE OF SECONDS. THE ALARM STOPPED BEFORE THE PATIENT COULD LOOK AT SYSTEM CONTROLLER. THE PATIENT DID NOT FEEL LIGHTHEADED OR HAVE ANY ISSUES. THE PATIENT WENT INTO THE CLINIC AND THE LOG FILE WAS REVIEWED AND MULTIPLE LOW SPEEDS AND THAT THE PUMP HAD STOPPED TWICE. HIGH POWER AND HIGH PI EVENTS WERE RECORDED ON OCCASION IN THE LOG FILE, AS WELL AS PUMP STOPPAGE W/O ANY POWER BEING DRAWN. X-RAYS WERE TAKEN OF THE LVAD PERCUTANEOUS (PERC) LEAD AND WERE INCONCLUSIVE AS TO ANY ISSUES. EXTERNAL MANIPULATION OF THE PERC LEAD DID NOT RESULT IN ANY ALARMS. AS A RESULT, THE PATIENT WAS GIVEN A MODIFIED PATIENT CABLE AND NO FURTHER ISSUES OR ALARMS HAVE BEEN REPORTED. THE PATIENT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 73568

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other