BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE

    MDR report key: 7544234 · Received May 17, 2018

    Report

    Report Number
    7544234
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    May 14, 2018
    Report Date
    May 15, 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) MALE WITH PMH OF HYN, AWMI, LV ANEURYSM WHO UNDERWENT DT LVAD AS DT ON (B)(6) 2017. PT PRESENTED WITH C/O DIPLOPIA AND GAIT DISTURBANCES. ON (B)(6) 2018 PT HAD AN INCREASE IN POWER GREATER THAN 10. INR AT THE TIME WAS 2.10. PT WENT FOR LVAD PUMP EXCHANGE ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366687 HEARTWARE HEARTWARE LVAD DSQ HEARTWARE-MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other