BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2497273 · Received March 12, 2012

    Report

    Report Number
    2916596-2012-00224
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 13, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED FOR POSSIBLE LOW SPEED LIMIT ALARMS WITH SUDDEN HIGH POWER OF 12-14W, PI AT 1, HEMATOCRIT (HCT) DOWN AND LDH UP. THE FAMILY REPORTED A LOW FLOW WITH PUMP STOP ALARM THE PREVIOUS EVENING. A BEDSIDE ECHO WAS PERFORMED WITH A RAMP STUDY, WITH NO COMPRESSION WHEN PUMP SPEED WAS INCREASED TO 12,000 RPM. A MASSIVE EMBOLIC EVENT IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 95667

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening