BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMABLE VALVE, RT ANGLE UNITIZED

    MDR report key: 1842033 · Received September 21, 2010

    Report

    Report Number
    1226348-2010-00302
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 6, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K980778
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED ABOUT AIR IN THE VENTRICLE, THE DRAINAGE WAS BLOCKED (UNALTERED DILATATION OF THE VENTRICLES), POSSIBLY A HOLE IN THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMABLE VALVE, RT ANGLE UNITIZED SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG CODMAN & SHURTLEFF, INC., MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention