BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 3041412 · Received April 8, 2013

    Report

    Report Number
    1226348-2013-15054
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 13, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK991273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS REQUESTED RETURN OF THE VALVE FOR EVALUATION. HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS OF THE VALVES AND OR CATHETERS HAVE REVEALED THE ACCUMULATIONS OF BIOLOGICAL DEBRIS WITHIN THE DEVICE, WHICH HAVE RESULTED IN BLOCKAGES. REVIEW OF THE DEVICE HISTORY RECORDS HAVE CONFIRMED THAT THE VALVES HAVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT WHEN THE DEVICE WAS RECEIVED THE PROXIMAL CONNECTOR WAS MISSING AND A CUT IN THE NEEDLE CHAMBER WAS ALSO OBSERVED. IT IS HOWEVER NOT CLEAR IF THIS OCCURRED DURING THE IMPLANT OR EXPLANTS OF THE DEVICE. THE LOT NUMBER RETURNED WAS ACTUALLY THAT OF PKK857 AND NOT PK857 AS INITIALLY REPORTED. UPON FURTHER INVESTIGATION AN OCCLUSION WAS NOTED AT THE INLET OF THE RUBY BALL. WHEN IRRIGATED AGAIN THE FLOW WAS NORMAL. WHEN TESTED FOR PRESSURE THE DEVICE FAILED. BIOLOGICAL DEBRIS WAS SEEN THROUGHOUT THE DEVICE, WHICH APPEARS TO HAVE BEEN THE ROOT CAUSE FOR THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. 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 AFFILIATE REPORTED THAT THE DEVICE WAS IMPLANTED VIA V-P SHUNT AT 140MMH2O. AFTER IMPLANTATION, IT WAS NOTED THAT FLUID DID NOT FLOW THROUGH THE DEVICE. AS A RESULT, THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143448 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. PPK857

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention