BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS THERAPY MGMT SYSTEM

    MDR report key: 3790047 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11528
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). AN INITIAL IS BEING GENERATED TO SUBMIT AN MDR RECLASSIFYING THE INCIDENT AS A MALFUNCTION. UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE EVALUATION OF THE TMS SYSTEMS DID NOT REVEAL ANY ANOMALIES. BOTH PROGRAMMERS WERE FULLY FUNCTIONAL AS RECEIVED. THE PROGRAMMING DIFFICULTIES ENCOUNTERED IN THE CLINICAL SETTING COULD NOT BE DUPLICATED IN THE LABORATORY. THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. BOTH PROGRAMMERS ARE FULLY FUNCTIONAL AND ANOMALY FREE. PROGRAMMING DIFFICULTIES WERE NOT FOUND WHEN EVALUATING THESE PROGRAMMERS. BASED ON THE INVESTIGATION THIS COMPLAINT IS CONSIDERED CLOSED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR EVENTS.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP. INFORMED THAT: "PATIENT WAS OVERDRAINING AT THE SETTING OF 4 SO THEY WANTED TO TURN THE VALVE UP TO 7. INDICATOR KEPT GIVING SETTING ALL OVER THE PLACE. NOTHING CONSISTENT. THEY GOT A DIFFERENT PROGRAMMER AND IT READ EXACTLY WHAT IT NEEDED TO BE 5 TIMES STRAIGHT. THEY ARE VERY EXPERIENCED WITH THIS PROGRAMMER AND SAID THEY WOULD LIKE TO SEND THIS ONE BACK FOR REPAIR/REPLACEMENT". ADDITIONAL E-MAILS RECEIVED FROM THE SALES REP. ON (B)(6) 2012, INFORMED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THEY JUST TRIED A DIFFERENT PROGRAMMER. ESTIMATED TIME DELAY WAS 10 TO 15 MINUTES. THE VALVE WAS ADJUSTED, THE TMS COULD NOT INDICATE THE SETTING; HOWEVER, WHEN THEY USED ANOTHER TMS UNIT, IT CONFIRM THE SETTING. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). AN INITIAL IS BEING GENERATED TO SUBMIT AN MDR RECLASSIFYING THE INCIDENT AS A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269370 CERTAS THERAPY MGMT SYSTEM SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF AM1108A

    Patients

    Seq Age Sex Outcome Treatment
    1