BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1910535 · Received November 19, 2010

    Report

    Report Number
    1226348-2010-00390
    Event Type
    Injury
    Date Received
    November 19, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS SA
    Product Code
    JXG
    PMA / PMN Number
    K974739
    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, IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. A VISUAL EXAMINATION OF THE VALVE REVEALED THAT THE STATOR WAS DISLODGED; THEREFORE, THE CAM POSITION AND PRESSURE COULD NOT BE DETERMINED. UPON FURTHER INVESTIGATION IT WAS REVEALED THAT THE VALVE CASING WAS CRACKED. IT IS LIKELY THAT THE DEVICE MAY HAVE SUSTAINED SOME FORM OF IMPACT CAUSING THE DAMAGE TO THE VALVE. THIS HOWEVER, COULD NOT BE CONFIRMED. ENHANCEMENTS WERE MADE TO THE STATOR STAMPING TOOL DURING THE 2004/2005 TIMEFRAME, WHICH WAS DESIGNED TO MINIMIZE THIS TYPE OF DISLODGEMENT. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION AND THAT THIS VALVE WAS MANUFACTURED PRIOR TO ENHANCEMENTS. 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 IT WAS NOTED THROUGH X-RAY THAT THE STEPPING MOTOR DETACHED FROM THE BASE PLATE. NO SYMPTOMS WERE NOTED WITH THE PT. THE DEVICE WAS REMOVED AND NO REVISION WAS NECESSARY AS THE PT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. MEDOS SA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention