BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE, RIGHT ANGLE RES. UNITIZED SG

    MDR report key: 4093547 · Received September 16, 2014

    Report

    Report Number
    1226348-2014-11973
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    May 27, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 82-3146, WITH LOT NUMBER CPKCG4, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE (B)(6) 2013. NO ROOT CAUSE COULD BE DETERMINED SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. 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

    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 NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP. INFORMED THAT: ¿MY SURGEON NOTIFIED ME YESTERDAY AFTERNOON THAT HE HAS THREE PATIENTS WHO RECEIVED SHUNTS OVER THE PAST SIX MONTHS WHO ARE SEVERELY OVER SHUNTING AND IT HAS CAUSED A COLLAPSE IN VENTRICLES ON EACH PATIENT¿. ADDITIONAL INFORMATION: ¿PATIENT HAD SHUNT PLACED FOR CHIARI MALFORMATION (B)(6) 2014 AND WE HAVE MADE SHUNT ADJUSTMENTS BASED ON CT SCANS. SHE CONTINUES TO HAVE LARGE VENTRICLE WITH THE SETTING SET HIGH". ALSO SEE COMPLAINTS # (B)(4).

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP. ON SEPTEMBER 15, 2014, PROVIDED INFORMATION REGARDING THE PRODUCT CODE NUMBER AND LOT NUMBER FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573631 HAKIM VALVE, RIGHT ANGLE RES. UNITIZED SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CPKCG4

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention