BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1760572 · Received July 14, 2010

    Report

    Report Number
    1226348-2010-00220
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 17, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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/PRESSURE COULD NOT BE DETERMINED. IT IS NOT CLEAR HOW THE DEVICE BECAME DISLODGED, HOWEVER, IT IS POSSIBLE THAT THE DEVICE SUSTAINED SOME KIND OF IMPACT. THIS HOWEVER, CANNOT BE CONFIRMED. THERE WAS AN ENHANCEMENT MADE TO THE STAMPING TOOL IN THE 2004/2005 TIMEFRAME. THE ENHANCEMENT WAS DESIGNED TO REDUCE THESE TYPES OF DISLODGEMENTS. THE DEVICE WAS MANUFACTURED PRIOR TO THE ENHANCEMENTS. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE 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.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE PATIENT SUFFERED HEADACHES AND AN UNSUCCESSFUL ATTEMPT CONCLUDED THAT THE DEVICE COULD NO LONGER BE PROGRAMMED. AN X-RAY CONFIRMED STATOR DISLODGEMENT. AS A RESULT THE DEVICE WAS REVISED.

    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 S.A. NA P.1378

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention