BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL VENTRICULAR DRAINAGE SET (EVDS)

    MDR report key: 2505334 · Received March 20, 2012

    Report

    Report Number
    9612007-2012-00007
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    PMA / PMN Number
    910853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE LENGTHS / DEPTHS MARKER WERE NOT AVAILABLE ON THE VENTRICULAR CATHETERS (B)(4). THE UNIT WAS IN CONTACT WITH A PATIENT, HOWEVER THERE WAS NO INJURY REPORTED WITH THIS EVENT. IT IS UNKNOWN IF THE PROCEDURE WAS DELAYED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL VENTRICULAR DRAINAGE SET (EVDS) EXTERNAL DRAINAGE SYSTEMS JXG INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1