BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 6116554 · Received November 21, 2016

    Report

    Report Number
    1226348-2016-10790
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 17, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE IMAGES WERE TAKEN OF THE ¿AS RECEIVED¿ VALVE. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 50MMH2O. THE VALVE WAS HYDRATED FOR 24 HOURS. THE VALVE WAS VISUALLY INSPECTED: A SMALL CUT WAS NOTED IN THE NEEDLE CHAMBER. THE VALVE WAS TESTED FOR PROGRAMMING WITH PROGRAMMER 82-3126 WITH SERIAL NUMBER (B)(4), THE VALVE PASSED THE TEST. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED, LEAKED FROM THE SMALL CUT IN THE NEEDLE CHAMBER. THE CATHETERS WERE IRRIGATED, NO OCCLUSIONS WERE NOTED. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE SIPHON GUARD WAS TESTED, LEAKED FROM THE SMALL CUT IN THE NEEDLE CHAMBER. THE VALVE WAS DRIED. THE SIPHON GUARD WAS REMOVED. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3162 WITH LOT CVFBBC, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 3RD MAY 2016. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. THE ROOT CAUSE FOR THE SMALL CUT IN THE NEEDLE CHAMBER IS PROBABLY DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING, THIS HOWEVER COULD NOT BE DETERMINED. AS NOTED IN THE IFU SILICONE HAS A LOW CUT / TEAR RESISTANCE. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED VIA V-P SHUNT TO (B)(6) FEMALE WITH HYDRENCEPHALUS ON (B)(6) 2016. THE INITIAL PRESSURE SETTING WAS 70 MM H20. AFTER IMPLANTATION, THE SURGEON WAS FOUND OCCLUSION OF THE DEVICE DUE TO SHUNT MALFUNCTION. THE DEVICE WAS REPLACED WITH 82-3832 SET AT 30 MM H20 ON (B)(6) 2016. THE PATIENT¿S CONDITION IS GOOD AFTER THE REVISION. THE SURGEON SUSPECTS THAT THE OCCLUSION OF PERITONEAL CATHETER. NO INFORMATION WAS PROVIDED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768691 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CVFBBC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention