BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVD - BECKER EDMS II

    MDR report key: 19885719 · Received July 31, 2024

    Report

    Report Number
    MW5157903
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    July 19, 2024
    Report Date
    July 29, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE PATIENT'S EVD WAS FOUND TO BE LEAKING CSF AT THE EVD CLIP. THE PATIENT HAD THE EVD SWITCHED OUT. NO OTHER KNOWN INJURY OTHER THAN LOSS OF CSF, SWITCH OUT OF THE EVD AND RISK OF INFECTION AT THIS TIME. THIS WAS REPORTED TO COMPANY REP ON THE DATE OF OCCURRENCE. THE NURSING MANAGER TO COORDINATE WITH COMPANY REP AND PROVIDE DEFECTIVE DEVICE FOR INVESTIGATION. MEDLINE INDUSTRIES, LP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241725 EVD - BECKER EDMS II DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC, INC. 46129

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention