BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIPHONGUARD, CSF FLD CONTROL DEVICE

    MDR report key: 1058474 · Received June 10, 2008

    Report

    Report Number
    1226348-2008-00161
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    May 13, 2008
    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
    JA
    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

    AFFILIATE REPORTED THAT THERE WAS A BREAKAGE OF THE SIPHON GUARD CONNECTOR. IT WAS IMPLANTED IN 2006 AND REPLACED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIPHONGUARD, CSF FLD CONTROL DEVICE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC./ MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention