BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 3140513 · Received May 31, 2013

    Report

    Report Number
    1226348-2013-17960
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 14, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE DEVICE FUNCTIONED PROPERLY. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. IT WAS HOWEVER NOTED THAT MANY NEEDLE HOLES WERE FOUND IN THE NEEDLE CHAMBER AND IT IS NOT CLEAR IF THAT HAD ANYTHING TO DO WITH THE FUNCTIONALITY OF THE DEVICE AS THE DEVICE FUNCTIONED PROPERLY WHEN TESTED. NO DISCREPANCIES WERE FOUND WHEN THE DEVICE WAS INSPECTED 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 PATIENT COMPLAINED OF SYMPTOMS THAT COULD BE RELATED TO VALVE PROBLEMS. AS A RESULT, THE SHUNT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240721 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. 1128897

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention