BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN BIOMEDICAL INC.

    MDR report key: 7240915 · Received February 1, 2018

    Report

    Report Number
    MW5075038
    Event Type
    Malfunction
    Date Received
    February 1, 2018
    Date of Event
    April 1, 2014
    Report Date
    January 26, 2018
    Manufacturer
    SORIN BIOMEDICAL INC.
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LVAD PLACED ON (B)(6) 2014 SECONDARY TO ADVANCE HEART FAILURE. PT DEVELOPED PANCYTOPENIA AND ACUTE KIDNEY FAILURE IN (B)(6) 2017. BLOOD CULTURES DONE ARE POSITIVE FOR MYCOBACTERIUM AVIUM COMPLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77920 SORIN BIOMEDICAL INC. HEAT EXCHANGER DTR SORIN BIOMEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other