BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 4151159 · Received October 8, 2014

    Report

    Report Number
    1226348-2014-12031
    Event Type
    Injury
    Date Received
    October 8, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    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

    THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 140MMH2O. THE VALVE WAS VISUALLY INSPECTED; A NEEDLE HOLE IN THE SILICONE HOUSING OVER THE NEEDLE STOP WAS NOTED. NO DEFECTS NOTED. THE CATHETERS WERE VISUALLY INSPECTED, AND A BREAK IN THE CATHETER WAS NOTED. THIS COULD BE DUE TO WRONG HANDLING, BUT THIS COULD NOT BE CONFIRMED. COMPLAINT CONFIRMED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3100, WITH LOT NUMBER CPFCFH, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 5TH JUNE 2013. THE ROOT CAUSE OF THE BROKEN CATHETER COULD BE DUE TO WRONG HANDLING, BUT THIS COULD NOT BE DETERMINED. A VISUAL INSPECTION IS DONE AT 100% BEFORE RELEASE. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS RE-OPENED AS ADDITIONAL INFORMATION WAS PROVIDED; UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. COMPLAINT SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    A FOLLOW UP REPORT IS BEING FILED AS THE SAMPLE WAS RETURNED TO THE INVESTIGATION SITE ON OCTOBER 21ST 2014. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE: ON (B)(6) 2014, THE DEVICE WAS IMPLANTED VIA V-P SHUNT FOR THE PATIENT WITH BRAIN TUMOR ((B)(6)) THE SETTING PRESSURE WAS 150MMH2O. ON (B)(6) 2014, THE PATIENT HAD DISORIENTATION. ON (B)(6) 2014, IT WAS CONFIRMED BY CONTRAST RADIOGRAPHY THAT THE ABDOMINAL CATHETER WAS BROKEN AND DISCONNECTED. ON (B)(6) 2014, THE REVISION SURGERY WAS CONDUCTED AND THE VALVE AND ABDOMINAL CATHETER WERE REPLACED BY THE SAME NEW PRODUCT (82-3100). THE SETTING PRESSURE WAS 150MMH2O. AFTER THE REVISION, THE PATIENT'S CONDITION WAS IMPROVED. THE REMOVED VALVE AND ABDOMINAL CATHETER WILL BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE SUSPECTED BREAKAGE OF THE VALVE OR CATHETER AFTER IMPLANTATION WAS REPORTED. FURTHER INFORMATION WOULD BE PROVIDED AS SOON AS JJKK RECEIVED FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632714 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPFCFH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention