BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE MICRO VALVE

    MDR report key: 4003784 · Received August 12, 2014

    Report

    Report Number
    1226348-2014-11887
    Event Type
    Injury
    Date Received
    August 12, 2014
    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

    GTIN NUMBER B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE 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 NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE VERIFIED. THE LOT NUMBER FOR THE DEVICE IS CJCB5W; PRODUCT CODE 82-3112. IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3112, WITH LOT NUMBER CJCB5W, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 11TH MARCH 2008. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    ROTOR DISLOCATED FROM BASEPLATE; PROGRAMMING OF THE VALVE NOT POSSIBLE. NO FURTHER INFORMATION AVAILABLE. UNKNOWN IF DEVICE REMAINS IMPLANTED OR IF IT HAS BEEN REVISED. B)(6) 2014: ADDITIONAL INFORMATION EXPLAINED THEY HAVE NOTICED, THAT MOST DISLOCATIONS HAVE BEEN DETECTED (BY X-RAY) RIGHT AFTER AN MRI STUDY. WE HAVE X-RAYS OF ALL VALVES THAT ARE CLAIMED TO HAVE A BROKEN ROTOR. ESPECIALLY CASE NUMBER NINE IS INTERESTING. WE HAVE AN X-RAY IMAGE RIGHT BEFORE AND AFTER AN MRI STUDY. THE ONE UPFRONT SHOWS THE ROTOR IN THE CORRECT PLACE. THE X-RAY, THAT HAS BEEN DONE RIGHT AFTER THE MRI STUDY SHOWS THE ROTOR DISLOCATED. UNFORTUNATELY, THE QUALITY IS TOO BAD TO SCAN THEM. ALL X-RAYS WILL BE SENT TO B)(6) PAPER BASED. THE OFFICIAL COMPLAINT FORMS HAVE BEEN UPDATED ACCORDINGLY. B)(6) 2014 ALSO REPORTED WAS THAT MRI MAGNETIC SETTING IS 1.5T. NO RELEVANT CHANGE IN MR-PROCEDURES IN THE LAST YEARS. IT WAS EXPLAINED THAT B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 8/21/2014 PERTAINING TO THE 10 COMPLAINTS WITH RESPECT TO THE PENDING QUESTIONS ON MRI SETTINGS AND POSSIBLE CHANGES IN THE MRI PROCEDURES. THE RADIOLOGIST OF THE HOSPITAL CONFIRMED THAT NONE OF THE PATIENTS HAD AN MRI WITH MORE THAN 3 TESLA. THE 10 PATIENTS TREATED IN 5 DIFFERENT MRI MACHINES (3 INTERNALLY, 2 EXTERNALLY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478477 HAKIM PROGRAMMABLE MICRO VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CJCB5W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention