BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VALVE

    MDR report key: 2970330 · Received February 20, 2013

    Report

    Report Number
    1226348-2013-12618
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    September 26, 2012
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE DEVICE RETURNED WAS NOT THAT OF A CODMAN PRODUCT. AS A RESULT THE DEVICE WAS NOT INVESTIGATED. INSTEAD THE DEVICE WAS RETURNED TO THE CUSTOMER. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SMILIAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT FLOW. THE CATHETER WAS TESTED AFTER REMOVAL AND WAS FINE. THEREFORE THE SURGEON BELIEVED THERE WAS A PROBLEM WITH THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73599 UNKNOWN VALVE SHUNT, CENTRAL NERVOUS SYSTEMS & COMPS JXG 296474

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention