BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1081265 · Received July 24, 2008

    Report

    Report Number
    1226348-2008-00187
    Event Type
    Injury
    Date Received
    July 24, 2008
    Manufacturer
    UNK
    Product Code
    JXG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE PT HAS EXPANDED VENTRICLES. INITIALLY THE PT'S VALVE WORKED FINE, AND THEN SHE RETURNED TO THE HOSPITAL WITH PRESSURE RELATED PROBLEMS. THE REP IS UNCLEAR OF MOST OF THE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SHUNT, CENTRAL NERVOUS SYTEM & COMPS JXG UNK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention