BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 3520493 · Received December 16, 2013

    Report

    Report Number
    1226348-2013-36044
    Event Type
    Injury
    Date Received
    December 16, 2013
    Date of Event
    November 22, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    UPON COMPLETION OF THE INVESTIGATION, THE VALVE WAS VISUALLY INSPECTED AND A SMALL SPOT OF BIOLOGICAL DEBRIS WAS NOTED IN THE SILICONE HOUSING BETWEEN THE VALVE MECHANISM AND THE DISTAL END OF THE VALVE. NO OCCLUSIONS WERE NOTED IN THE VALVE. THE DEVICE WAS 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 TO HAVE HEALTH PROBLEMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE AFFILIATE TO CLARIFY THE HEALTH PROBLEMS. ADDITIONAL INFORMATION HAS NOT YET BEEN PROVIDED, HOWEVER, BASED ON THE SYNERGY FORM, IT INDICATES THAT THE COMPLAINT IS A POTENTIAL ADVERSE EVENT WITH POSSIBLE LEGAL ACTIONS. IT ALSO INDICATES THAT THE DEVICE WILL BE RETURNED, WHICH MIGHT SUGGEST THAT THE DEVICE WAS REVISED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE AFFILIATE STATED: THE O.H.O PATIENT (B)(6), WITH OBSTRUCTIVE HYDROCEPHALUS TUMOR, IS PLACED CODMAN PROGRAMMABLE VALVE (B)(4). IN (B)(6) 2012, THE PATIENT HAD HEADACHE AND STATES THAT THE PLACE YOU STARTED TO FEEL THE VALVE. IN (B)(6) 2013 THE SYSTEM IS CHECKED BUT THE SPECIALIST DID NOT FIND PROBLEMS WITH THE VALVE, SO THAT REQUESTS JYJ REVISED. THE PATIENT IS WITHDRAWN VALVE AND THE WILL MAKE AN INTERNAL VENTRICULAR SHUNT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656369 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC CNJB2N

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention