BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 4003703 · Received August 12, 2014

    Report

    Report Number
    1226348-2014-11886
    Event Type
    Injury
    Date Received
    August 12, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOTED THAT THE PRODUCT CODE IS 82-3100 AND NOT 82-3110 AS PREVIOUSLY REPORTED. IT WAS ALSO NOTED THAT THE LOT NUMBER WAS 828886 AND NOT PN2341 AS PREVIOUSLY REPORTED. VISUAL EXAMINATION OF THE VALVE REVEALED THAT THE STATOR WAS DISLODGED. THEREFORE; THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. IT WAS NOTED THAT THE VALVE CASING WAS CRACKED, AND A BUMP MARK FROM THE CAM MECHANISM WAS FOUND IN THE VALVE CASING, THIS IS DUE TO THE VALVE SUSTAINING SOME FORM OF IMPACT. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3100 WITH LOT 828886, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 7TH DECEMBER 2000. THE ROOT CAUSE OF THE DISLODGEMENT IS DUE TO THE VALVE SUSTAINING SOME FORM OF IMPACT. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    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).

    Description of Event or Problem · 1

    ROTOR DISLOCATED FROM BASEPLATE; PROGRAMMING OF THE VALVE NOT POSSIBLE. VALVE WAS EXCHANGED WITH THE SAME LIKE DEVICE. PRODUCT WILL BE RETURNED. DETECTION OF DEFECT BY X-RAY WAS (B)(6) 2014. LAST MRI WAS (B)(6) 2014. (B)(6) 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 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478736 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. 828886

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention