BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 4192954 · Received October 22, 2014

    Report

    Report Number
    1226348-2014-12063
    Event Type
    Injury
    Date Received
    October 22, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION 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. DEVICE IS STILL IMPLANTED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THIS REPORT IS FOR THE RECORD. AFTER IMPLANTATION, IT WAS FOUND BY RADIOGRAPHY THAT THE STEPPING MOTOR WAS DISLODGED FROM THE BASE PLATE. DOI AND THE SETTING PRESSURE ARE UNKNOWN. SINCE THE FLUID FLOWS THROUGH THE DEVICE WITHOUT PROBLEM, THE REVISION IS UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673943 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention