BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 6140857 · Received December 2, 2016

    Report

    Report Number
    1226348-2016-10829
    Event Type
    Injury
    Date Received
    December 2, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE MAKE AVAILABLE FOR EVALUATION. HOWEVER, IT APPEARS THAT THE DEVICE REMAINS IMPLANTED. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. A REVIEW OF MANUFACTURING RECORDS FOUND NO DISCREPANCIES WHEN THE DEVICE WAS RELEASED TO STOCK. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT FAMILY MEMBER, HIS GIRLFRIEND, UNKNOWN AGE, WHO HAS A HISTORY OF ACOUSTIC NEUROMA AND HYDROCEPHALUS, UNDERWENT IMPLANTATION OF A CODMAN CERTAS PLUS VALVE ON AN UNKNOWN DATE AND HAD AN UNEXPECTED PROGRAMMING CHANGE AND ADDITIONAL IMAGING FOR DIAGNOSIS. IT WAS REPORTED THAT THE SURGICAL NOTES DOCUMENT AN INITIAL PRESSURE SETTING OF 5. APPROXIMATELY 13 DAYS POST IMPLANTATION; THE PATIENT AND REPORTER WERE SEEN IN THE SURGEON¿S OFFICE BY A NURSE, WHO IDENTIFIED THE SETTING TO BE AT 4. THIS WAS AN UNEXPECTED PROGRAMMING CHANGE. THE PATIENT WAS SENT TO THE ER FOR IMAGING, A CT WAS DONE AND IT WAS REPORTED THAT IT SHOWED POSSIBLE OVER DRAINAGE. THE VALVE WAS ADJUSTED WHILE THE PATIENT WAS IN THE ER TO A SETTING OF 6. APPROXIMATELY TWO WEEKS AFTER THE ADJUSTMENT TO SETTING OF 6, AN MRI WAS DONE. IT WAS REPORTED BY THE COMPLAINANT THAT SHOWED INCREASING SPACE BETWEEN THE BRAIN AND THE SKULL. AT THIS TIME THERE IS NO DEVICE SPECIFIC INFORMATION AVAILABLE. THE REPORTER DECLINED TO PROVIDE AND PATIENT SPECIFIC INFORMATION. NO DELAY REPORTED.

    Description of Event or Problem · 1

    UPDATE PER PHONE CALL WITH INITIAL REPORTER: IT WAS REPORTED THAT THE INITIAL SETTING OF THE VALVE WAS RECORDED AS 5 AT IMPLANT, BUT THAT AT THE FIRST FOLLOW UP VISIT IT WAS FOUND BY THE NURSE TO BE SET AT 4 USING THE TOOL KIT. THE NURSE THEN ADJUSTED IT TO 5. THE INITIAL REPORTER SAID HIS GIRLFRIEND HAD BEEN HAVING FEELING OF ¿WATER ON THE BRAIN¿ OR ¿UNDERWATER¿ AND VOMITING. INITIAL REPORTER THEN STATED THAT LATER THAT DAY, AFTER PROXIMITY 3 HOURS, A CT SCAN WAS DONE, WHICH SHOWED EVIDENCE OF A HEMATOMA, SUSPECTED TO HAVE BEEN CAUSED BY OVER-DRAINAGE. IT WAS STATED THAT THEY WOULD WAIT FOR IT TO REABSORB BEFORE SURGERY. HE THEN SAID THAT ON (B)(6) SHE STILL WAS HAVING TROUBLE AND THE SHUNT WAS AGAIN CHANGED TO 6 AFTER 2 WEEKS OF FOLLOW UP BUT ONLY TO FIND AN INCREASE IN THE SIZE OF THE HEMATOMA. THE PATIENT WAS ADMITTED FOR EVACUATION AND DRAINAGE OF THE HEMATOMA. THE INITIAL REPORTED NOTED PLACEMENT OF A EVD. HE SAID A FEW DAYS LATER THE EVD WAS REMOVED AT BESIDE AND THE SHUNT WAS SET TO 8. HE SAYS THAT THE SHUNT IS NOW SET TO 7 AND SHE IS AWAITING PRE-OP FOR HER ACOUSTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793067 CERTAS INLIN VLV ONLY W/SPHNGD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CVKBG2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention