BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMABLE VALVE SYSTEM SPECIAL DEVICE

    MDR report key: 1652778 · Received April 6, 2010

    Report

    Report Number
    1226348-2010-00095
    Event Type
    Injury
    Date Received
    April 6, 2010
    Date of Event
    March 6, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THE STAIR STEP WHEEL ON PROGRAMMABLE VALVE BROKE FREE FROM FACEPLATE AND IS FREE FLOATING WITHIN THE HOUSING OF THE VALVE. THERE WAS NO PATIENT INJURY. REP EXPLAINED THAT THE ISSUE WAS FOUND THROUGH A CT SCAN ON FRIDAY (B) (6). AS A RESULT THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMABLE VALVE SYSTEM SPECIAL DEVICE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPS JXG CODMAN & SHURTLEFF, INC., MEDOS S.A. NA PL3036

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention