BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE W/ PRECHAMBER

    MDR report key: 3879610 · Received June 18, 2014

    Report

    Report Number
    1226348-2014-11712
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    March 18, 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 VALVE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED VALVE DID CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER WAS CPMBPP, SERIAL NUMBER (B)(4), PRODUCT CODE 82-3110. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 160MMH2O. THE VALVE WAS TESTED FOR PROGRAMMING AND THE VALVE FAILED THE TEST, DURING THE PROGRAMMING TEST THE CAM MECHANISM DID NOT MOVE. THE VALVE WAS IRRIGATED WITH PURIFIED WATER; NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED; A LEAK WAS NOTED ON THE SIDE OF THE VALVE THIS COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING. THE VALVE WAS REFLUX TESTED, THE VALVE FAILED THE TEST. THE VALVE WAS RETESTED FOR PROGRAMMING; THE VALVE FAILED THE TEST. THE VALVE WAS THEN PRESSURE AT 160MMH2O, FAILED.THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, ON THE CAM MECHANISM, ON THE CAM MECHANISM PILLAR, AND ON THE BASE PLATE. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3110 WITH LOT NUMBER CPMBPP, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 3RD DECEMBER 2013. THE ROOT CAUSE OF THE PROBLEM FOUND DURING INVESTIGATION IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, ON THE CAM MECHANISM, ON THE CAM MECHANISM PILLAR, AND ON THE BASE PLATE. THE ROOT CAUSE OF THE LEAK IN THE SILICONE HOUSING, COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING, BUT THIS COULD NOT BE DETERMINED. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. 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 INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THERE WAS A SHUNT SURGERY LAST MARCH. AFTER THE SURGERY THE HCP TRIED TO CHANGE THE PRESSURE BUT IT DIDN'T WORK AT ALL. SO, THEY TRIED THE PRESSURE SETTING WITH ANOTHER CODMAN HAKIM PROGRAMMER BUT IT DIDN'T WORK AS WELL. THUS, THEY DECIDED TO DO REVISION RECENTLY. I'LL SEND THE DEFECTIVE SHUNT(82-3110) WHEN WE RECEIVE IT. RESPONSE FROM CUSTOMER WHEN ASKED IF A LOT NUMBER WAS AVAILABLE: NO, THE DISTRIBUTOR THAT IS IN CHARGE OF THIS ACCOUNT DOESN'T RECORD LOT NUMBERS AND NEITHER DO WE. DO YOU THINKS IT'S NECESSARY TO KEEP TRACK OF IT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357979 HAKIM PROGRAMMABLE VALVE W/ PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPMBPP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention