BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE MEDTRONIC

    MDR report key: 13228550 · Received January 10, 2022

    Report

    Report Number
    13228550
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    October 20, 2021
    Report Date
    November 29, 2021
    Manufacturer
    MEDTRONIC
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ADMITTED TO HOSPITAL WITH ELEVATED LOH AND DARK URINE, LDH CONT TO UPTREND WITH HF SYMPTOMS, PT TAKEN FOR HEARTWARE: HM3 PUMP EXCHANGE, TOLERATED WELL. POST OP COURSE UNCOMPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223645 HEARTWARE MEDTRONIC MEARTWARE LVAD DSQ MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| L