BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II

    MDR report key: 3030023 · Received March 28, 2013

    Report

    Report Number
    3030023
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 28, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT REPORTED PROBLEMS WITH UNIT. PT C/O OF DIZZINESS AND NOSEBLEEDS. PUMP EVALUATED AND LOW VOLTAGE ALARMS. SYSTEM CONTROLLER AND PATIENT CABLE REPLACED. THIS IS ONE OF FOUR EVENTS IN APPROXIMATELY FOUR MONTHS WITH THIS DEVICE IN DIFFERENT PATIENTS AT THIS FACILITY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127677 HEARTMATE II VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION HEARTMATE II *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR