BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE

    MDR report key: 7553447 · Received May 29, 2018

    Report

    Report Number
    7553447
    Event Type
    Injury
    Date Received
    May 29, 2018
    Date of Event
    May 10, 2018
    Report Date
    May 11, 2018
    Manufacturer
    HEARTWARE-MEDTRONIC
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MALE WITH PMH OF HYN, AWMI, LV ANEURYSM WHO UNDERWENT DT LVAD AS DT ON (B)(6) 2017. PATIENT PRESENTED WITH C/O DIPLOPIA AND GAIT DISTURBANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393385 HEARTWARE HEARTWARE LVAD DSQ HEARTWARE-MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other