BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 1002531 · Received February 26, 2008

    Report

    Report Number
    1226348-2008-00039
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 24, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A
    Product Code
    JXG
    PMA / PMN Number
    K020667
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFO IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFO, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT, THE DEVICE AND/OR LOT INFO DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW-UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT IT WAS FOUND THAT AFTER A MRI THE PRESSURE OF THE VALVE CHANGED FROM 140MMH2O TO 180MMH2O. THE DOCTOR TRIED TO CHANGE THE PRESSURE, BUT THE DEVICE WOULD NOT REPROGRAM. THE DEVICE WAS NOT REVISED AS THE PT'S CONDITION IS STABLE

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention