BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PV INLINE SG INTEGRAL CON ML

    MDR report key: 2161919 · Received July 11, 2011

    Report

    Report Number
    1226348-2011-00257
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    April 24, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE PATIENT BEGAN EXHIBITING SYMPTOMS OF CURRENT CONDITION 5 DAYS AGO, BEING CHARACTERIZED BY ABDOMINAL DISTENSION. IMAGE STUDIES OF THE ABDOMEN WERE UNDERTAKEN USING ULTRASOUND. A PSEUDOCYST FORMATION IN THE ABDOMEN WAS IDENTIFIED IN THIS STUDY. A SAMPLE OF CEREBROSPINAL FLUID WAS TAKEN THROUGH A PUNCTURE OR THE VALVE RESERVOIR FOR CYTOLOGICAL AND BACTERIAL CULTURE ANALYSIS. CYTOLOGICAL RESULTS OF THE CEREBROSPINAL FLUID HAS BEEN RECEIVED, AND IT REVEALED HYPER-CELLULARITY PLUS HYPER-PROTEINORRACHIA (HIGH PROTEIN LEVELS DETECTED IN THE CSF). AS A RESULT OF THESE FINDINGS, IT WAS DECIDED TO REMOVE THE SHUNTING SYSTEM AND TO PLACE AN EXTERNAL VENTRICLE SHUNTING PLUS ANTIBIOTIC THERAPY (VANCOMYCIN AND CEFOTAXIMA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PV INLINE SG INTEGRAL CON ML SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC., MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR