BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 1872391 · Received October 11, 2010

    Report

    Report Number
    1226348-2010-00331
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC, MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K061876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT COULD NOT BE CONFIRMED. THE PROGRAMMING UNIT WAS FOUND FULLY FUNCTIONAL. THE FALSE/POSITIVE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. THE RADIOPAQUE MARKER ISSUE REPORTED BY THE CUSTOMER COULD NOT BE VERIFIED, AS THE VALVE IS STILL IMPLANTED IN THE PT. 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 PMA/510(K): K050739.

    Description of Event or Problem · 1

    REP REPORTED THAT A PROGRAMMER HAS POTENTIALLY MALFUNCTIONED. PT ADMITTED INTO THE HOSPITAL FOR OBSERVATION. THE PROBLEM THEY ENCOUNTERED WAS THAT THE RADIOPAQUE MARKER WAS NOT VISIBLE ON THE X-RAY. ADDITIONALLY, THE VALVE WAS REPROGRAMMED TO 160MMH20 WITH THE VPV. THEY REC'D A CONFIRMATION MESSAGE, BUT THE X-RAY SHOWED THE PT WAS STILL AT 120MMH20. FALSE/POSITIVE. PT STATUS IS GOOD AND THE DEVICE WAS LEFT AT 120MMH20.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK (B)(4)