BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CODMAN SHUNT

    MDR report key: 6031666 · Received October 14, 2016

    Report

    Report Number
    1226348-2016-10727
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    April 1, 2016
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PART NUMBER, UDI UNAVAILABLE. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IN THE LITERATURE SEARCH, ¿ROLE OF LUMBOPLEURAL SHUNT IN MANAGEMENT OF IDIOPATHIC INTRACRANIAL HYPERTENSION¿ PUBLISHED WORLD NEUROSURGERY 88: 113-118, APRIL 2016, IT WAS REPORTED THAT (B)(6) YEAR-OLD FEMALE PATIENT EXPERIENCED SHUNT MIGRATION POST IMPLANTATION OF AN UNKNOWN CODMAN SHUNT THAT WAS TREATED BY INSERTION OF ANOTHER DEVICE. PER THE ARTICLE: ¿IDIOPATHIC INTRACRANIAL HYPERTENSION (IIH) DENOTES THE CONDITION OF INCREASED INTRACRANIAL PRESSURE WITHOUT A CLEAR UNDERLYING PATHOLOGIC CONDITION OF THE BRAIN. THE TREATMENT PLAN SHOULD BE CONDUCTED TO SAVE VISION. TREATMENT OPTIONS INCLUDE MEDICATIONS, SERIAL LUMBAR PUNCTURES, AND SURGICAL INTERVENTION. SURGERY IS INDICATED ONCE VISUAL LOSS CONTINUES DESPITE OPTIMUM MEDICAL THERAPY¿.. THE MAIN CAUSE OF FAILURE WAS SHUNT MIGRATION¿ ONCE MIGRATION WAS NOTED IN THIS PATIENT, A SECOND DEVICE WAS IMPLANTED ON THE OTHER SIDE AND THE EMIGRATED DEVICE WAS LEFT IN PLACE WITHOUT FURTHER INTERVENTION. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681716 UNK CODMAN SHUNT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention