BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 2143095 · Received June 23, 2011

    Report

    Report Number
    1226348-2011-00224
    Event Type
    Injury
    Date Received
    June 23, 2011
    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 Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT A VISUAL EXAMINATION REVEALED THAT THE STATOR WAS DISLODGED. AS A RESULT THE POSITION AND PRESSURE OF THE DEVICE COULD NOT BE DETERMINED. UPON FURTHER EXAMINATION, IT WAS FOUND THAT NO DEFECTS WERE NOTED ON THE VALVE CASING OR THE CAM. AS A RESULT, THE ROOT CAUSE FOR THE DISLODGEMENT OF THE DEVICE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATION PRIOR TO DISTRIBUTION. ENHANCEMENTS WERE MADE TO THE DESIGN OF THIS DEVICE IN THE 2004/2005 TIMEFRAME. IT WAS DETERMINED THAT THIS DEVICE WAS MANUFACTURED PRIOR TO THE ENHANCEMENT OF THIS DEVICE. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTON 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 THE STEPPING MOTOR DETACHED FROM THE BASE PLATE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention