BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2963473 · Received February 13, 2013

    Report

    Report Number
    2916596-2013-00172
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. 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 VAD COORDINATOR THAT THE PATIENT FELL, BUT HAD NO IMMEDIATE PROBLEMS. FIVE DAYS LATER, THE LOG FILE WAS REVIEWED AND PUMP STOPS WERE NOTED. THE PATIENT REPORTED HEARING 2 SHORT "CHIRPS". THE PATIENT WAS ASYMPTOMATIC DURING THE EVENTS. ABDOMEN AND CHEST X-RAYS WERE TAKEN AND THERE WERE NO SIGNS OF WIRE FRACTURE. AN ECHOCARDIOGRAM (ECHO) SHOWED NORMAL VAD PLACEMENT, LABS WERE NORMAL AND THERE WERE NO SIGNS OF HEMOLYSIS. THE SYSTEM CONTROLLER WAS EXCHANGED WITH ANOTHER SYSTEM CONTROLLER AND AT THIS TIME, IT WAS NOTED THAT THE PERCUTANEOUS LEAD WAS UNLOCKED. THE PATIENT COULD NOT REMEMBER THE LAST TIME HE VERIFIED THAT THE PERCUTANEOUS LEAD LOCK ON THE SYSTEM CONTROLLER WAS SECURELY LOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63782 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 111114

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention