BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HV LUMBAR VALVE SYSTEM.

    MDR report key: 374661 · Received January 31, 2002

    Report

    Report Number
    9612007-2002-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2002
    Date of Event
    November 21, 2001
    Report Date
    December 6, 2001
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT FROM THE FIELD INDICATED THAT A LUMBAR HYDROCEPHALUS SHUNT, WAS TESTED PRIOR TO USE IN A PATIENT, AND THE SEPARATED LUMBER ANTECHAMBER WAS FOUND DEFECTIVE (LEAK AT THE CONNECTION). NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HV LUMBAR VALVE SYSTEM. HYDROCEPHALUS VALVE JXG NMT NEUROSCIENCES IMPLANTS S.A. NA 113758

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other