BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 2190990 · Received July 29, 2011

    Report

    Report Number
    1226348-2011-00281
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 1, 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
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE STATOR WAS DISLODGED. UPON FURTHER INVESTIGATION IT WAS ALSO NOTED THAT NO OTHER DAMAGE TO THE DEVICE WAS FOUND, THEREFORE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS PROBLEM. ENHANCEMENTS WERE MADE TO THE MANUFACTURING OF THIS DEVICE DESIGN IN THE 2004/2005 TIMEFRAME. THE ENHANCEMENT WAS DESIGNED TO MINIMIZE THIS TYPE OF DISLODGEMENT. ACCORDING TO THE REVIEW OF THE DEVICE HISTORY RECORDS THEY CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. THE RECORDS ALSO CONFIRMED THAT THIS DEVICE WAS MANUFACTURED PRIOR TO THE ENHANCEMENT. 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 DUE TO PATIENT SYMPTOMS A CT SCAN REVEALED THAT THE VALVE MECHANISM WAS DISLOCATED.

    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 42 YR Required Intervention