BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2193493 · Received July 21, 2011

    Report

    Report Number
    2916596-2011-00308
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    December 15, 2010
    Report Date
    June 24, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEERING TECH REPORTED AN ARTIFACT WHEN OBTAINING HEART RHYTHMS ON INPATIENTS. MOVING THE ELECTRODES, TRANSMITTER AND WIRES WOULD NOT GIVE CONSISTENT RESULTS. THIS NOISE IS NOT SEEN ON THE "HARD WIRED" BEDSIDE MONITORS OR THE 12 LEAD SYSTEMS. EQUIPMENT USED FOR THE PROCEDURE: SPACELABS, ULTRAVIEW DIGITAL TELEMETRY ECG TRANSMITTER, 90347-05, (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention