BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 2210449 · Received August 9, 2011

    Report

    Report Number
    2916596-2011-00339
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 11, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY HOSP PERSONNEL THAT THE PT AND HIS WIFE REPORTED 2 SMALL BEEPS ABOUT 2.5 MINUTES APART WHILE THEY WERE SLEEPING, HOWEVER, NO VISUAL ALARMS WERE SEEN ON THE SYSTEM CONTROLLER OR POWER MODULE. THEY DROVE TO THE HOSP EMERGENCY ROOM AND THE SYSTEM CONTROLLER WAS CHECKED AND PASSED ALL TESTING. THE HISTORY SCREEN DID NOT DISPLAY ANY ALARMS THAT HAD TAKEN PLACE. THE PT WAS PLACED ON A STROKE VOLUME LIMITER. WAVE FORMS AND LOG FILES WERE SENT TO THE MFR FOR REVIEW AND THE RESULTS WERE REPORTED BACK TO THE HOSP AS NORMAL. FIVE DAYS LATER, THE MFR WAS NOTIFIED THAT A PUMP EXCHANGE FROM ONE LVAD TO ANOTHER LVAD HAD TAKEN PLACE. THE PT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1270 69504

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention