BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE INLINE UNIT (INTEGRAL CON)

    MDR report key: 7072764 · Received November 30, 2017

    Report

    Report Number
    1226348-2017-10905
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    October 31, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    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 IT WAS NOTED THAT THE IMAGES WERE TAKEN OF THE ¿AS RECEIVED¿ VALVE. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 40 MMH2O. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING WITH PROGRAMMER 82-3126 WITH SERIAL (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. NO LEAKS NOTED. THE VALVE WAS REFLUX TESTED. THE VALVE PASSED THE TEST. THE VALVE WAS DRIED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3844, WITH LOT CMLBNN, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 4TH OCTOBER 2011. NO ROOT CAUSE COULD BE DETERMINED; AS NO PROBLEM WAS NOTED WITH THE VALVE. 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.

    Additional Manufacturer Narrative · 1

    IT WAS INCORRECTLY REPORTED THAT THE DEVICE WAS RECEIVED ON 27 NOV 2017. THE DEVICE WAS RETURNED ON 24 NOV 2017. THIS REPORT HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SHUNT DYSFUNCTION - (B)(6) 2017 REVISION AND VALVE REPLACEMENT, VALVE STORED IN THE OPERATING ROOM (OR). MVV SUPPLEMENTATION: INCREASE IN VENTRICLES, OP, SINCE V.A. SHUNT DISORDER - OUTFLOW CONTROLLED INTRAOPERATIVELY, HAS WORKED, THEREFORE SUSPECTED DYSFUNCTION INTERMEDIATE PART OF THE VALVE. VALVE IS STILL STORED IN THE OPERATING ROOM (OR).

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED IN 2014 AND ALREADY REVISED IN 2016. DYSFUNCTION (B)(6) 2017. REVISION AND CHANGE OF THE VALVE THE REMAINING SHUNT PARTS (CRANIAL AND PERITONEAL DRAINS SHOWED NO DEFECT) (B)(6) - (B)(6) 2017 PER AFFILIATE: "PATIENT HAD TO BE OPERATED TO FIND THE PROBLEM. CT SHOWED PROGRESSIVE VENTRICLE VOLUME, WHEN DECIDED TO DO A SHUNT REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851644 HAKIM VALVE INLINE UNIT (INTEGRAL CON) SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CMLBNN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention