BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 5401959 · Received February 1, 2016

    Report

    Report Number
    1226348-2016-10102
    Event Type
    Injury
    Date Received
    February 1, 2016
    Date of Event
    January 19, 2016
    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

    THE DEVICE WAS RETURNED AND EVALUATED. THE ISSUE REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. A CUT ON TRANSMITTER CABLE WAS OBSERVED, WHICH DOES NOT IMPACT VPV FUNCTIONALITY. THE PRODUCT WAS FORWARDED TO OUR SUPPLIER (B)(4) FOR REPAIR. THE TRANSMITTER CABLE, TRANSMITTER COVER, TRANSMITTER SWITCH AND DOME PLUG HAS BEEN REPLACED. A DHR REVIEW WAS PERFORMED FOR THE VPV PROGRAMMER 82-3192, (B)(4) (LOT#CJFDHD), AND THE LOT MET SPECIFICATIONS WHEN RELEASED ON (B)(4) 2008. REGARDING THE PROGRAMMING ISSUE REPORTED BY THE CUSTOMER, NO ROOT CAUSE COULD BE DETERMINED AS THE VPV PROGRAMMER WORKS NORMALLY. THE ROOT CAUSE OF THE CUT ON TRANSMITTER CABLE IS DUE TO AN USER ERROR. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IMPLANTATION OF CERTAS PLUS VALVE. THE SURGEON REPORTED THE PATIENT HAD VALVE CHANGING PRESSURE OUTSIDE OF PROGRAMMING, AND PATIENT WAS COMPLAINING OF HEADACHES AND DRAINING. THEY RESET VALVE AND WHEN X-RAY WAS TAKEN TO CHECK THE VALVE WAS SET CORRECTLY IT HADN'T BEEN SET AS EXPECTED. IT WASN'T ON THE SETTING THEY HAD SET ON THE PROGRAMMER. THEY ARE QUESTIONING IF FAULT IS WITH VPV OR REGISTRAR PROGRAMMING IT, OR IF PATIENT WAS SUBJECTED TO UNUSUAL MAGNETIC FIELD. THEY WANTED TO EXCLUDE THAT THE VALVE WASN'T FAULTY. VALVE WAS REMOVED AND REPLACED WITH PROGRAMMING COMPLETED WITH ANOTHER PROGRAMMER. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59550 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CJFDHD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention