BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRICLEAR II VENTRICULAR DRAINAGE COLLECTION SYSTEM

    MDR report key: 5001451 · Received August 6, 2015

    Report

    Report Number
    MW5055355
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 16, 2015
    Report Date
    August 6, 2015
    Manufacturer
    MEDTRONIC NEUROLOGICAL TECHNOLIGIES
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(4) MALE ADMITTED FOR SAH AND HYDROCEPHALUS ON (B)(6) 2015. EVD PLACED ON (B)(6) 2015 FOR SAH. ON (B)(6) 2015, PT TRANSFERRED FROM CT SCANNER TO BED. DURING TRANSFER, THE EVD PRESSURE CABLE WAS CAUGHT ON PT'S BED AND PULLING ON EVD. WHILE LOOSENING PRESSURE CABLE. RN FOUND THE EVD BAG HAD DISLODGED FROM EVD. NO PT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520843 VENTRICLEAR II VENTRICULAR DRAINAGE COLLECTION SYSTEM MEDTRONIC DUET EVD DRAINAGE BAG JXG MEDTRONIC NEUROLOGICAL TECHNOLIGIES UNK E144371301

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR