BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 2190869 · Received July 28, 2011

    Report

    Report Number
    1226348-2011-00280
    Event Type
    Injury
    Date Received
    July 28, 2011
    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 F/U REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE SILICONE HOUSING WAS TORN. IT IS POSSIBLE THAT THIS MAY HAVE OCCURRED WHEN THE PATIENT FELL. THIS HOWEVER CANNOT BE CONFIRMED. DURING ADDITIONAL TESTING OF THE DEVICE IT WAS ALSO FOUND THAT THE DEVICE FAILED THE PROGRAMMING TESTS AS WELL AS DETECTION OF AN OCCLUSION. WHEN THE DEVICE WAS IRRIGATED THE FLOW WAS NORMAL. BIOLOGICAL DEBRIS WAS FOUND THROUGHOUT THE DEVICE, WHICH APPEARS TO BE THE CAUSE FOR THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORDS 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.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT AFTER THE PT FELL AND HIT HIS HEAD ON THE FLOOR THERE WAS CSF THAT HAD ACCUMULATED SUBCUTANEOUSLY. AS A RESULT THE DEVICE WAS REVISED. UPON REMOVAL OF THE DEVICE IT WAS FOUND THAT THE SILICONE HOUSING WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC, MEDOS S.A. NA CKGC6Z

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention