BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 3870101 · Received June 12, 2014

    Report

    Report Number
    1226348-2014-11703
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 16, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE VALVE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED VALVE DID NOT CONFIRM A CLICKING SOUND. THE LOT NUMBER WAS CPGC31, SERIAL NUMBER (B)(4), PRODUCT CODE 82-3162. THE VALVE WAS VISUALLY INSPECTED AND IT WAS NOTED THAT THE VALVE CASING HAS TURNED INSIDE THE SILICONE HOUSING, THIS COULD BE DUE TO TOO MUCH PRESSURE WHEN FLUSHING THE VALVE BEFORE IMPLANTATION, BUT THIS COULD NOT BE DETERMINED. AFTER STERILIZATION THESE VALVES ARE PROGRAM TESTED IN THEIR PACKAGING, IF THE CASING WAS PUT TOGETHER WRONG THIS TEST WOULD NOT HAVE BEEN POSSIBLE AND THE VALVE WOULD HAVE BEEN REJECTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED, AND NO CLICKING SOUND WAS NOTED. THE VALVE WAS DRIED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3162 WITH LOT NUMBER CPGC31, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 16TH JULY 2013. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED AS NO CLICKING SOUND WAS NOTED WHEN THE VALVE WAS IRRIGATED. THE ROOT CAUSE FOR THE TURNED VALVE CASING COULD BE DUE TO TOO MUCH PRESSURE WHEN FLUSHING THE VALVE BEFORE IMPLANTATION. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS COMPLAINING OF CLICKING SOUND IN HER HEAD. THE PATIENT WENT BACK INTO SURGERY AND THE SHUNT WAS REMOVED. (DURING USE ON PATIENT.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348434 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPGC31

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention