BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE MICRO VALVE

    MDR report key: 4733123 · Received April 28, 2015

    Report

    Report Number
    1226348-2015-10246
    Event Type
    Injury
    Date Received
    April 28, 2015
    Date of Event
    March 18, 2009
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK980778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE VISUAL EXAMINATION OF THE VALVE REVEALED THAT THE STATOR WAS DISLODGED THEREFORE; THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: A SLIGHT SCRATCH MARK WAS NOTED IN THE VALVE CASING. CORROSION ON THE EDGE OF THE STATOR WAS OBSERVED. THE CAM MAGNETS WERE ALSO CONTROLLED. THE MAGNETS WERE OK. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3112, WITH LOT CJJBJR, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 7TH AUGUST 2008. THE ROOT CAUSE FOR THE PROGRAMMING PROBLEM IS DUE TO THE STATOR BEING DISLODGED. THE ROOT CAUSE OF THE STATOR DISLODGEMENT COULD NOT BE CLEARLY DETERMINED. NO CORRECTIVE ACTION WAS TAKEN AS THE ROOT CAUSE WAS NOT IDENTIFIED; A DATA REVIEW IS BEING OPENED TO TRACK ACTIONS RELATED TO GALVANIC CORROSION OF THE HAKIM VALVE BASE PLATE. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    EXPLANTATION AFTER DISLOCATION OF STATOR DUE TO MRT & X-RAY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278757 HAKIM PROGRAMMABLE MICRO VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CJJBJR

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention