BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 5217281 · Received November 11, 2015

    Report

    Report Number
    1226348-2015-10659
    Event Type
    Injury
    Date Received
    November 11, 2015
    Date of Event
    September 30, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK061876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE PRODUCT WAS RECEIVED IN (B)(4) THE NOVEMBER 6TH, 2015. THE PRODUCT WAS TESTED AND THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE PRODUCT WAS FORWARDED TO OUR SUPPLIER HMT. THE INVESTIGATION ON THE SUPPLIER DETECTED THAT THE TRANSMITTER WAS BROKEN, FRONT PANEL DAMAGED AND ONE LED AT TRANSMITTER DAMAGED. COIL FEETS, FRONT PANEL AND THE DEFECTUOUS LED HAS BEEN REPLACED, AND PROGRAMMER WORKS AGAIN. A DHR REVIEW WAS PERFORMED FOR THE VPV PROGRAMMER 82-3192, S/N: (B)(4) (LOT#CLCCDR), AND THE LOT MET SPECIFICATIONS WHEN RELEASED ON FEBRUARY 19TH, 2010. THE ROOT CAUSE OF THE PROBLEM IS DUE TO A SUSPECTED USER ERROR, THIS HOWEVER COULD NOT BE DETERMINED. 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

    510(K) #S: K061876 & K050739. GTIN: (B)(6). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE SETTING OF A VLAVE WAS ADJUSTED USING THE DEVICE WITH THE PACKAGED VALVE MODE BEFORE IMPLANTATION. ON (B)(6) 2015, SINCE THE PATIENT'S CONDITION GOT WORSE AFTER IMPLANTATION, THE SURGEON TRIED TO CHANGE THE SETTING PRESSURE AND FOUND THAT IT HAD CHANGED AUTOMATICALLY. THE SETTING PRESSURE WAS CHANGED WITH THE PROGRAMMER (82-3190) AND THEN THE PATIENT'S CONDITION WAS IMPROVED. ACCORDING TO THE SURGEON, THE "COMPLETE" MESSAGE WAS DISPLAYED THOUGH THE BEEP WAS SHORTER THAN USUAL. AT AN OPERATION CHECK CONDUCTED LATER, THE SAME PHENOMENON WAS OBSERVED AND IT WAS ALSO FOUND THAT THE CAM OF THE VALVE WAS NOT ROTATING . THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746877 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CLCCDR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention