BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHPV I-L/S W/PLAT UN120CM DIST

    MDR report key: 3041414 · Received April 8, 2013

    Report

    Report Number
    1226348-2013-15034
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK053350
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THIS COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND WAS FOUND TO WORK IN ACCORDANCE WITH THE MANUFACTURING SPECIFICATIONS. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTIONS. 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

    THE AFFILIATE REPORTED THAT THE PATIENT BEGAN HAVING SYMPTOMS OF HYDROCEPHALUS. AS A RESULT, THE DEVICE WAS REVISED AS THE SURGEON SUSPECTED A DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142835 CHPV I-L/S W/PLAT UN120CM DIST SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. 428535

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention