BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMABLE VALVE, RT ANGLE W/SIPHONGUARD

    MDR report key: 2060851 · Received March 11, 2011

    Report

    Report Number
    1226348-2011-00107
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 23, 2011
    Manufacturer
    CODMAN AND SHURTLEFF, INC. MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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

    REP REPORTED THAT DURING AN INTRA-OPERATIVE PROCEDURE, THE SURGEON BELIEVES, THE VALVE DOES NOT FUNCTION PROPERLY. AFTER CONNECTING THE VALVE TO BOTH THE VENTRICULAR AND PERITONEAL CATHETERS, SURGEON WAS NOT ABLE TO ESTABLISH FLOW THROUGH THE SHUNT SYSTEM. AS A RESULT THE DEVICE WAS NOT USED, BUT SURGERY WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMABLE VALVE, RT ANGLE W/SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM AND COMPS JXG CODMAN AND SHURTLEFF, INC. MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR