BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVANOVA / SORIN

    MDR report key: 6958147 · Received October 18, 2017

    Report

    Report Number
    MW5072817
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    September 25, 2017
    Report Date
    October 16, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    READMISSION WITH FEVER ON (B)(6) 2017. FEVER FOR 7 DAYS, NONPRODUCTIVE COUGH FOR THE PAST 3 WEEKS, DYSPNEA ON EXERTION AND GENERALIZED FATIGUE. PT'S TEMPERATURE GOES AS HIGH AS 104 DEGREES FAHRENHEIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739421 LIVANOVA / SORIN 3T HEATER COOLER DWC SORIN GROUP DEUTSCHLAND GMBH 16-02-82

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization