BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN HAKIM VALVE PROGRAMMER & TRANSMITTER

    MDR report key: 3030547 · Received April 2, 2013

    Report

    Report Number
    1226348-2013-14741
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK061876
    Product Problem
    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, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT DURING THE INVESTIGATION IT WAS FOUND THAT THE TRANSMITTER CABLE IS DAMAGED. THE DAMAGE APPEARS TO BE CONSISTENT WITH USER HANDLING. THIS HOWEVER COULD NOT BE CONFIRMED. THE PROGRAMMER WAS TESTED ACCORDING TO SPECIFICATIONS AND ALL TESTS CONCLUDED THAT THE DEVICE PERFORMED IN ACCORDANCE WITH OUR INTERNAL TEST METHOD. 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

    THE AFFILIATE REPORTED THAT AFTER VERIFYING PRESSURE, IT WAS NOTICED THAT THE PROGRAMMING PRESSURE WAS CHANGED TO A RANGE OF 80. RADIOGRAPHY SHOWED A PRESSURE RANGE OF 120. NO OTHER DETAILS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134314 CODMAN HAKIM VALVE PROGRAMMER & TRANSMITTER VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. 10666

    Patients

    Seq Age Sex Outcome Treatment
    1