BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 3241275 · Received July 22, 2013

    Report

    Report Number
    1226348-2013-21815
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    May 5, 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 THE COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE DEVICE RETURNED WAS 82-3100 AND NOT THAT OF 82-3110 AS INITIALLY REPORTED. IT WAS ALSO FOUND THAT THE STATOR WAS DISLODGED. THEREFORE THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. UPON FURTHER EXAMINATION IT WAS ALSO FOUND THAT THE VALVE WAS CRACKED AND A BUMP MARK WAS FOUND IN THE VALVE CASING. IN ADDITION, THE CAM MECHANISM WAS ALSO DAMAGED. ALTHOUGH THE EXACT ROOT CAUSE OF THE PROBLEM FOUND WITH THE DEVICE COULD NOT BE DETERMINED IT MIGHT BE POSSIBLE THAT THE DEVICE WAS SUSTAINED TO SOME FORM OF IMPACT. THIS HOWEVER COULD NOT BE DETERMINED. A REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THAT THE VALVE 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

    THE AFFILIATE REPORTED THAT THERE WERE MULTIPLE FAILURES TO REPROGRAM THE VALVE AND THERE WERE CLEAR CLINICAL SIGNS OF DYSFUNCTION. AS A RESULT, THE VALVE WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE WHEEL OF THE VALVE MECHANISM HAD BEEN DISLOCATED AND RESIDED IN THE SILICONE CHAMBER, PARTLY OBSTRUCTING THE CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340650 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. P.863

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention