BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSV II

    MDR report key: 383226 · Received March 19, 2002

    Report

    Report Number
    9612007-2002-00003
    Event Type
    Malfunction
    Date Received
    March 19, 2002
    Date of Event
    August 9, 2000
    Report Date
    February 22, 2002
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A VALVE REPLACEMENT SURGERY, THE NEW VALVE WAS TESTED AND LEAKED. THE OLD SYSTEM WAS RE-IMPLANTED. A NEW SURGERY WAS PERFORMED LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSV II HYDROCEPHALUS VALVE JXG NMT NEUROSCIENCES IMPLANTS S.A. NA 104519

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention