BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT SORIN 3T HCD

    MDR report key: 6181547 · Received December 15, 2016

    Report

    Report Number
    MW5066735
    Event Type
    Injury
    Date Received
    December 15, 2016
    Report Date
    December 15, 2016
    Manufacturer
    LIVANOVA, FORMERLY SORIN
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HOSPITALIZED IN (B)(6) 2016 WITH OSTEOMYELITIS STERNUM. INITIAL TESTING POSITIVE FOR MYCOBACTERIUM CHIMAERA. FURTHER TESTING UNDERWAY. RESULTS NOT YET BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825673 STOCKERT SORIN 3T HCD STOCKERT SORIN 3T HCD DWC LIVANOVA, FORMERLY SORIN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other