BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 6066830 · Received October 31, 2016

    Report

    Report Number
    1226348-2016-10763
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    October 6, 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 A CERTAS VALVE AND 5MM OF PERITONEAL CATHETER WERE RETURNED FOR EVALUATION TO CODMAN SWITZERLAND. NO DEFECT WAS NOTED FOR THE VALVE. THE INVESTIGATION OF THE RETURNED 5MM OF CATHETER DID CONFIRM THAT THE CATHETER WAS BROKEN. THE LOT NUMBER IS FOR THE CERTAS VALVE IS UNKNOWN, PRODUCT CODE 82-8804. THE LOT NUMBER IS FOR THE CATHETER IS UNKNOWN, PRODUCT CODE 82-3045. THE 5MM OF CATHETER WAS VISUALLY INSPECTED: THE EDGE SEEMS TO BE CLEAN CUT, WITHOUT THE REST OF THE CATHETER IT IS NOT POSSIBLE TO DETERMINE THE CAUSE. NO ROOT CAUSE COULD BE DETERMINED, AS ONLY A SMALL PIECE OF CATHETER WAS RETURNED. IT IS POSSIBLE THAT A SHARP OR POINTED OBJECT HAS COME INTO CONTACT WITH THE CATHETER, THIS HOWEVER COULD NOT BE DETERMINED. IF THE REST OF THE CATHETER IS RETURNED IN THE FUTURE THIS COMPLAINT WILL BE REOPENED AND THE REST OF THE CATHETER INVESTIGATED. 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

    ON (B)(6) 2016, THE DEVICE WAS IMPLANTED VIA L-P SHUNT WITH 82-8804 + 82-3045 + 702JJ TO A (B)(6) MALE. ON (B)(6) 2016, IT WAS FOUND THAT CONNECT PARTS OF ABDOMINAL CATHETER WAS BROKEN, AND THE REPLACEMENT SURGERY WAS PERFORMED. LUMBAR CATHETER WAS CONTINUED TO USE. THE VALVE AND ABDOMINAL CATHETER WERE REPLACED BY A DEVICE WHICH UNITIZED VALVE AND CATHETER. THE PATIENT'S CONDITION IS GOOD AFTER THE REVISION. ABDOMINAL CATHETER WHICH WAS IMPLANTED ON THE INITIAL SURGERY IS REMAINED THE PATIENT BODY. NO FURTHER PATIENT INFORMATION DATA AND OTHER INFORMATION WERE PROVIDED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718201 CERTAS INLIN VLV ONLY W/SPHNGD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 82-3045