BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS THERAPY MGMT SYSTEM

    MDR report key: 3812651 · Received May 15, 2014

    Report

    Report Number
    1226348-2014-11627
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 30, 2013
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT 2 TMS PROGRAMMERS WERE RECEIVED (ONE WAS MISSING THE ADJUSTMENT TOOL). WHEN TESTING BOTH RETURNED INDICATOR TOOLS IT WAS VERIFIED THAT THE BLACK BUTTON STICKS SLIGHTLY AFTER DEPRESSING; CAUSING THE DIFFICULTIES REPORTED. THIS ISSUE IS CONSISTENT WITH PRIOR COMPLAINTS FOR THIS PRODUCT CODE. THE VENDOR IMPLEMENTED (B)(4) TO UPDATE NOTES ON THE SPRING (USED IN THE TMS INDICATOR) DRAWING TO CALL OUT NUMBER OF ACTIVE COILS, DEAD COILS, AND CONCENTRIC COILS. FURTHERMORE, EXISTING SPRING PERMITS COILS TO COLLAPSE ON EACH OTHER UPON FULL COMPRESSION OF THE INDICATION TOOL BUTTON. IN SOME CASES THE BUTTON COULD BECOME STUCK OR "CLICK" AS IDENTIFIED IN (B)(4). TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS FOR THIS PRODUCT CODE. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    REP REPORTED THAT THE TMS UNIT IS NOT CONSISTENTLY GIVING THE CORRECT NUMBER. SECOND TMS UNIT WILL NOT SEAT IN PROPERLY AND STOP AT #2. NO ADVERSE CONSEQUENCES WERE REPORTED TO THE REP, WHICH WAS CONFIRMED ON (B)(4). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290918 CERTAS THERAPY MGMT SYSTEM SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF

    Patients

    Seq Age Sex Outcome Treatment
    1