BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE

    MDR report key: 8678125 · Received June 3, 2019

    Report

    Report Number
    8678125
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 26, 2019
    Report Date
    May 30, 2019
    Manufacturer
    HEARTWARE INC
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 1

    A (B)(6) Y/O MALE WITH H/O HTN, DM COMPLICATED BY DIABETIC NEPHROPATHY. CAD STATUS POST LVAD (B)(6) 2018 HAD PERSISTED RIGHT PERIPHERAL VISION LOSS APPARENTLY FOR PAST 3 WEEKS DID NOT SEEK MEDICAL CARE. HEAD CT ON (B)(6) 2019 AT OUTSIDE HOSP SHOWS LEFT OCCIPITAL LOBE INFARCT LIKELY IN SETTING OF ISCHEMIA. INR WAS THERAPEUTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454957 HEARTWARE HEARTWARE LVAD DSQ HEARTWARE INC HVAD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O NO.