BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMABLE VALVE INLINE

    MDR report key: 2991452 · Received March 6, 2013

    Report

    Report Number
    1226348-2013-13160
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 8, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE NEEDLE BASE HAS COME AWAY FROM THE VALVE NEEDLE CHAMBER. IT IS NOT POSSIBLE TO DETERMINE HOW OR WHEN THIS OCCURRED. NO OTHER DAMAGE WAS NOTED. DURING FURTHER EVALUATION OF THE DEVICE IT WAS FOUND THAT THE DEVICE FAILED THE PROGRAMMING TEST AS THE CAM MECHANISM DID NOT MOVE. IN ADDITION, IT WAS NOT POSSIBLE TO PRESSURE TEST THE DEVICE SINCE THE NEEDLE BASE WAS NO LONGER ATTACHED TO THE VALVE. IT WAS ALSO FOUND THAT BIOLOGICAL DEBRIS WAS SEEN THROUGHOUT THE DEVICE. A REVIEW OF THE DEVICE HISTORY CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT THE VALVE WAS VERY DIFFICULT TO PROGRAM FOR THAT LAST YEAR - SURGEON MOVED VALVE TO 200MM PRESSURE AND STILL FELT IT WAS OVER DRAINING. HE WOULD LIKE US TO TEST THE VALVE FUNCTIONALITY AND SEND HIM A REPORT VIA EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95933 PROGRAMMABLE VALVE INLINE SHUNT, CENTRAL NERVOUS SYSTEM, & COMPS JXG CODMAN & SHURTLEFF, INC. 82-3834 CKMCFK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention