BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSV II

    MDR report key: 246142 · Received October 22, 1999

    Report

    Report Number
    9612007-1999-00029
    Event Type
    Malfunction
    Date Received
    October 22, 1999
    Date of Event
    October 6, 1999
    Report Date
    October 20, 1999
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VENTRICULAR CATHETER IS 7 CM INSTEAD OF 9 CM. THIS WAS FOUND PRIOR TO IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSV II Implant HYDROCEPHALUS VALVE JXG NMT NEUROSCIENCES IMPLANTS S.A. NA 20399319

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other