BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLINE VLV W/ SPHNGRD

    MDR report key: 6186426 · Received December 19, 2016

    Report

    Report Number
    1226348-2016-10864
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    November 25, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K112156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 3. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE WAS HYDRATED FOR 24 HOURS. THE VALVE WAS TESTED FOR PROGRAMMING. THE VALVE PASSED THE TEST. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED, ONLY LEAKED FROM THE NEEDLE HOLES IN THE NEEDLE CHAMBER. THE SIPHON GUARD WAS TESTED. THE VALVE PASSED THE TEST. 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 WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOWN. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. 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 WITH V-P SHUNT DUE TO HYDROCEPHALUS (DOI AND INITIAL SETTING WAS UNK). AFTER CEREBRAL HEMORRHAGE WAS OCCURRED, THE FUNCTIONAL OF DEVICE GOT WORSE, SO SHUNT SYSTEM RESPONSE BECAME DULL. ON (B)(6) 2016, THE DEVICE WAS REPLACED WITH 82-8805 DUE TO SUSPECTED OCCLUSION THROUGH CONTRAST RADIOGRAPHY. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837313 CERTAS INLINE VLV W/ SPHNGRD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention