BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 4411764 · Received January 13, 2015

    Report

    Report Number
    1226348-2015-10029
    Event Type
    Injury
    Date Received
    January 13, 2015
    Date of Event
    January 5, 2015
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK061976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510(K): K061876 & K050739. 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 REPORT FROM HMT FOUND THAT: NO FAILURE WAS FOUND. THE VPV PROGRAMMER ACCELEROMETER WAS RE-GLUED, AND THE TRANSMITTER CABLE REPLACED. THE VPV PROGRAMMER WAS VERIFIED. THE ROOT CAUSE OF THE PROBLEM COULD NOT BE DETERMINED AS NO FAILURE WAS FOUND BY HMT. 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

    PATIENT BORN IN 1982 WENT INTO CLINICIAN'S CLINIC FOR A LP SHUNT REPROGRAMMING. AN XRAY WAS TAKEN IN CLINIC BEFORE THE REPROGRAMMING AND READ 140MM H20. THE SURGEON AND HIS PA SET THE VPV PROGRAMMER TO 120MM AND ATTEMPTED NUMEROUS TIMES TO REPROGRAM THE VALVE. AFTER TWO HOURS WITH NO SUCCESS, THEY DECIDED TO SEND THE PATIENT BACK TO XRAY TO SEE IF THE VALVE HAD SUCCESSFULLY REPROGRAMMED TO 120MM H20. THE XRAY SHOWED THE VALVE HAD REPROGRAMMED TO 150/160MM H20 WHICH WAS AN UNINTENTIONAL REPROGRAMMING. THE PA AND SURGEON CALLED ME, I BROUGHT IN A DIFFERENT VPV PROGRAMMER, WE PROGRAMMED THE VALVE TO 120MM H20. WE WERE NOT ABLE TO GET A "ADJUSTMENT COMPLETE" PROMPT, SO THE PATIENT WENT TO X-RAY. X-RAY CONFIRMED THE VALVE REPROGRAMMED TO 120MM H2). ON 1/9/2015 ADDITIONAL INFORMATION PROVIDED IN A PHONE CALL FROM THE REP EXPLAINED THAT THE SECOND VPV USED BELONGED TO THE REP AND WAS GIVEN TO THE HOSPITAL TO USE FOR BACK UP. THE UNIT REMAINS IN USE AT THE FACILITY. THE UNIT DID NOT GIVE A CONFIRMATION COMPLETE, HOWEVER PER THE IFU THE X-RAY CONFIRMED THAT THE DEVICE WAS SET TO THE DESIRED SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29698 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF V06574

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention