BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIPHONGUARD, CSF FLD CONTRL DV

    MDR report key: 1694222 · Received May 18, 2010

    Report

    Report Number
    1226348-2010-00158
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    April 22, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DEVICE WAS ADDED TO AN EXISTING VENTRICULAR PERITONEAL SHUNT ON (B) (6) 2009. THE SHUNT HAD BEEN IN PLACE FOR A LONG TIME. ALTHOUGH THE EXACT LENGTH OF TIME IS UNK, IT WAS PUT IN WHEN THE PT WAS VERY YOUNG AND THE PT IS NOW A TEENAGER. THE VALVE IS A COMPETITOR DEVICE, THE MODEL NUMBER IS UNK. THE J&J DEVICE FUNCTIONED FOR APPROX 2 1/2 MONTHS UNTIL THE PT BECAME SYMPTOMATIC - STOPPED DRAINING. THE J&J DEVICE WAS ORIGINALLY IMPLANTED AT THE DISTAL END OF THE PERITONEUM. IT WAS SURGICALLY EXPLANTED AND REPLACED ON (B) (6) 2010. THE PT WAS FINE FOLLOWING THE PROCEDURE; THEY WILL CONTINUE TO MONITOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIPHONGUARD, CSF FLD CONTRL DV SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. NA CKCBY4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention