BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS THERAPY MGMT SYSTEM

    MDR report key: 3143193 · Received June 3, 2013

    Report

    Report Number
    1226348-2013-18073
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 17, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE DEVICE WAS TESTED AND WAS FULLY FUNCTIONAL. IT MIGHT HOWEVER BE POSSIBLE THAT IS THE VALVE WAS PROTRUDING THROUGH THE INDICATOR TOOL (WHILE IMPLANTED), AND THEN EXCESSIVE PRESSURE APPLIED TO THE BUTTON, WHICH WOULD PREVENT FREE ROTATION OF THE INDICATOR DIAL. HOWEVER, THIS COULD NOT BE VERIFIED IN THE LABORATORY. CHANGES ARE PRESENTLY UNDERWAY TO PREVENT THIS FROM OCCURRING. THE LOT RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED. 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

    THIS REPORT IS BEING FILED FROM MALFUNCTION TO SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP. INFORMED THAT: "DURING A REPROGRAMMING OF A CERTAS VALVE THE RN COULD NOT INDICATE PRE OR POST REPROGRAMMING. ATTEMPTED SEVERAL TIMES TO REPOSITION, BUT STILL COULDN'T GET AN INDICATION SO PATIENT SENT TO X-RAY AND X-RAY SHOWED THE SETTING CHANGED TO THE DESIRED SETTING. PATIENT'S CONDITION IS GOOD". THIS REPORT IS BEING FILED FROM MALFUNCTION TO SERIOUS INJURY.

    Description of Event or Problem · 1

    REP REPORTED THAT DURING A REPROGRAMMING OF A CERTAS VALVE THE RN COULD NOT INDICATE PRE OR POST REPROGRAMMING. ATTEMPTED SEVERAL TIMES TO REPOSITION, BUT STILL COULDN¿T GET AN INDICATION SO PATIENT SENT TO X-RAY AND X-RAY SHOWED THE SETTING CHANGED TO THE DESIRED SETTING. PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244805 CERTAS THERAPY MGMT SYSTEM SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention