BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMABLE VALVE IN-LINE WITH SIPHONGUARD

    MDR report key: 3875334 · Received June 16, 2014

    Report

    Report Number
    1226348-2014-11706
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 8, 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

    PLEASE NOTE: THE SERIAL NUMBER WAS CORRECTED AND THE EXPIRATION DATE WAS ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED DEVICE CONFIRMS THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER WAS CMGDFP, SERIAL NUMBER (B)(4), PRODUCT CODE 82-3832. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 90MMH2O. THE VALVE WAS VISUALLY INSPECTED; A NEEDLE HOLE WAS NOTED IN THE NEEDLE CHAMBER. THE VALVE WAS TESTED FOR PROGRAMMING; THE VALVE FAILED THE TEST, DURING THE PROGRAM PROCESS THE CAM MECHANISM DID NOT MOVE. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE SIPHON GUARD WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED AND A LEAK FROM THE PROXIMAL CONNECTOR WAS FOUND AS WELL AS A LEAK FORM THE NEEDLE HOLE IN THE NEEDLE CHAMBER. THE VALVE WAS REFLUX TESTED. THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED AT 90MMH20, THE VALVE PASSED THE TEST. THE PROXIMAL CONNECTOR WAS VISUALLY INSPECTED; IT WAS NOTED THAT THE CONNECTOR MOVED IN THE SILICONE HOUSING. THEN THE PROXIMAL CONNECTOR WAS REMOVED FROM THE SILICONE HOUSING AND IT WAS INSPECTED: NO DEFECTS WERE NOTED IN THE MOLDING OF THE SILICONE HOUSING OR ON THE CONNECTOR. THE VALVE WAS DISMANTLED; BIOLOGICAL DEBRIS WAS NOTED ON THE SPRING, ON THE SPRING PILLAR, ON THE SEAT OF RUBY BALL, ON 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 82-3832, LOT NUMBER CMGDFP, WAS CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 1ST JULY, 2011. THE ROOT CAUSE FOR THE PROBLEM REPORTED BY THE CUSTOMER 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 AND CAM PILLAR AND ON THE BASE PLATE. THE LEAK OF PROXIMAL CONNECTOR IS PROBABLY DUE TO USER ERROR DURING VALVE EX-PLANTATION, 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

    THE PATIENT IS MALE AND (B)(6), DIAGNOSED AS INTRACRANIAL ARACHNOID CYST. THE SURGEON DID V-P PROCEDURE ON (B)(6) 2012. NO ABNORMALITIES FOUND DURING THAT SURGERY. AFTER ONE YEAR, THE PATIENT HAD DIZZINESS, HEADACHE AND VOMITING AS WELL AS STANDING PROBLEM. THE PRESSURE COULD NOT BE ADJUSTED. THE SURGEON HAD TO REMOVE THE VALVE AND IMPLANT A NEW DEVICE ON (B)(6) 2013. THE PATIENT IS FINE AND DISCHARGED NOW (AFTER USE ON PATIENT). (B)(4) 2014 ADDITIONAL INFORMATION FROM THE AFFILIATE STATED: JUST GOT UPDATE FROM SALES REP, THE LOT NUMBER IS CMGDFP. (B)(4) 2014 DEVICE EXPLANTATION DATE WAS REMOVED FROM MEDWATCH; EMAIL SENT TO CUSTOMER REQUESTING CLARIFICATION ON EXPLANTATION/EVENT DATE. WILL SUBMIT FOLLOW UP REPORT ONCE THIS INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352518 PROGRAMMABLE VALVE IN-LINE WITH SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CMGDFP

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention