BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 5396076 · Received January 28, 2016

    Report

    Report Number
    5396076
    Event Type
    Malfunction
    Date Received
    January 28, 2016
    Date of Event
    December 11, 2014
    Report Date
    November 17, 2015
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: CARDIOMYOPATHY. PROCEDURE: RE-DO STERNOTOMY - HEARTWARE PUMP EXCHANGE. POST-OP DIAGNOSIS: CARDIOMYOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54848 HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR