BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE MICRO VALVE

    MDR report key: 4003870 · Received August 12, 2014

    Report

    Report Number
    1226348-2014-11889
    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

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE VERIFIED. THE LOT NUMBER FOR THE DEVICE IS CJLCL9; 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 CJLCL9, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE (B)(6) 2008. 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 COMPLAINT WAS RE-OPENED AS THE DEVICE WAS RETURNED FOR INVESTIGATION. UPON COMPLETION OF THE VISUAL EXAMINATION OF THE VALVE IT REVEALED THAT THE STATOR WAS DISLODGED. THEREFORE; THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. DURING THE FUNCTIONAL TESTING OF THE DEVICE IT WAS FOUND TO HAVE FAILED THE MAGNET TEST AS WELL AS THE POLARITY TEST. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. THE ROOT CAUSE(S) OF THE DISLODGEMENT COULD NOT BE DETERMINED. HOWEVER, THIS VALVE WAS MANUFACTURED PRIOR TO ENHANCEMENTS INTRODUCED TO THE STATOR STAMPING TOOL DURING 2004/2005 THAT WAS DESIGNED TO MINIMIZE THIS TYPE OF DISLODGEMENT. BASED ON THE RESULTS OF THIS INVESTIGATION WE CONSIDER THIS COMPLAINT TO BE CLOSED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    (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

    (B)(4). THIS COMPLAINT WAS RE-OPENED AS IT WAS COMMUNICATED FROM THE AFFILIATE THAT WHEN THE PRODUCT WAS RETURNED FOR INVESTIGATION IT WAS LABELED WITH THE WRONG COMPLAINT NUMBER. AS A RESULT A FOLLOW UP IS BEING FILED TO UPDATE THE INVESTIGATION. DURING THE INVESTIGATION IT WAS NOTED THAT DURING 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: IT WAS NOTED THAT THE VALVE CASING WAS CRACKED AND HAD AN IMPRINT MARK FROM THE CAM MECHANISM WHICH APPEARS TO HAVE BEEN THE RESULT OF THE DEVICE SUSTAINING SOME FORM OF IMPACT. THIS HOWEVER COULD NOT BE CONFIRMED. A REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3112, WITH LOT CJLCL9 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 17TH OCTOBER 2008. 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

    ROTOR DISLOCATED FROM BASEPLATE; PROGRAMMING OF THE VALVE NOT POSSIBLE. VALVE IS STILL IMPLANTED. LAST MRI (B)(6) 2014. DETECTION OF DEFECT BY X-RAY (B)(6) 2014. 8/5/2014: ADDITIONAL INFORMATION EXPLAINED THEY HAVE NOTICED, THAT MOST DISLOCATIONS HAVE BEEN DETECTED (BY XRAY) RIGHT AFTER AN MRI STUDY. WE HAVE X-RAYS OF ALL VALVES THAT ARE CLAIMED TO HAVE A BROKEN ROTOR. ESPECIALLY CASE (B)(6) 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)(4) PAPER BASED. THE OFFICIAL COMPLAINT FORMS HAVE BEEN UPDATED ACCORDINGLY. 8/8/2014: 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
    480870 HAKIM PROGRAMMABLE MICRO VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CJLCL9

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention