BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAME READY SYSTEM

    MDR report key: 1060885 · Received June 13, 2008

    Report

    Report Number
    2954777-2008-00002
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 22, 2008
    Manufacturer
    COOLSYSTEMS, INC.
    Product Code
    IRP
    PMA / PMN Number
    K071050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL CONTACT FROM DISTRIBUTOR ON MAY 7, 2008 WAS A REQUEST FOR INFO, NOT A COMPLAINT. THE QUESTION WAS WHETHER OR NOT WE HAD PRIOR REPORTS OF RSD BECAUSE ONE OF HIS ACCOUNTS BELIEVED HE MAY HAVE HAD TWO SUCH CASES AND BECAUSE HIS SURGICAL PROCEDURE WAS UNCHANGED, WONDERED IF IT WAS ASSOCIATED WITH HIS NEWLY ADOPTED USE OF GAME READY IN HIS POST-OP MANAGEMENT REGIME. THERE WAS NO REPORT OF DEVICE MALFUNCTION. WE KNOW THAT APPROX. 1.2 MILLION PTS HAVE USED GAME READY IN 6 YEARS WITH NO PRIOR REPORTS OF RSD. OF NOTE, AN ANKLE WRAP WAS USED ON THIS BUNIONECTOMY PT AND IT DOES NOT COVER THE TOES. RSD/CRPS IS A SYNDROME WITH VARIED SYMPTOMS AND SEVERITY, BUT GENERALLY REPRESENTED BY WIDESPREAD PAIN. IT IS REPORTED TO HAVE MULTIPLE POSSIBLE CAUSES AND NO KNOWN "CURE", ALTHOUGH CRYOTHERAPY IS OFTEN USED TO HELP MANAGE THE PAIN. THUS, WE DID NOT INITIALLY CONSIDER THIS A COMPLAINT OR ADVERSE EVENT. HOWEVER, WE DID FOLLOW UP WITH OUR CHIEF MEDICAL ADVISOR, A PHYSIATRIST, ON THAT SAME DAY AND HE ALSO DID NOT BELIEVE THAT THE USE OF GAME READY COULD LEAD TO THE DEVELOPMENT OF CRPS. AT OUR REQUEST, HE CONTACTED THE SURGEON DIRECTLY, TO FOLLOW UP WITH HIM. ON MAY 22, 2008 WE WERE TOLD THAT THE SURGEON HAD REPORTED THE PT SYMPTOMS WHICH CLEARLY REPRESENT AN INJURY THAT SHOULD BE REPORTED WITHIN 30 DAYS, REGARDLESS OF RELATEDNESS. THE GAME READY SYSTEM USED BY THIS PT PERFORMED AS INTENDED AND, BECAUSE THIS IS NOT A SINGLE-US DEVICE AND IT DID NOT MALFUNCTION, IT WAS PUT BACK INTO THE RENTAL FLEET OF THE DISTRIBUTOR FOR USE WITH OTHER PTS BEFORE WE COULD REQUEST ITS RETURN AND HAS CONTINUED TO BE USED WITHOUT INCIDENT OR MALFUNCTION.

    Description of Event or Problem · 1

    THE PT, A WOMAN, UNDERWENT BUNIONECTOMY SURGERY IN 2008, FOLLOWED BY POST-OPERATIVE THERAPY WITH ELEVATION AND CRYOTHERAPY WITH GAME READY. ON POST-OP DAY 17, THE PT REPORTED SYMPTOMS OF INITIAL HYPEREMIA, FOOT SWELLING AND SENSITIVITY TO TOUCH (ALLODYNIA). THE SURGEON CONCLUDED THAT THIS WAS A RESULT OF THE PT HAVING DEVELOPED REFLEX SYMPATHETIC DYSTROPHY (RSD), ALSO KNOWN AS COMPLEX REGIONAL PAIN SYNDROME (CRPS). THERE WAS NO REPORT OF PRODUCT MALFUNCTION. THE SURGEON WAS UNCERTAIN OF THE RELATIONSHIP TO OUR PRODUCT SO ASKED OUR DISTRIBUTOR IF THERE WERE OTHER RSD CASES REPORTED BY GAME READY USERS (THE ANSWER IS 'NO'). THE DISTRIBUTOR CALLED US ON MAY 7, 2008 WITH THIS QUESTION. OUR RESEARCH AND OUR EXPERT ADVISOR FOUND THAT TYPICALLY RSD OR CRPS DEVELOPS OFTEN AS A RESULT OF TRAUMA (E.G., SURGERY) BUT THE SPECIFIC CAUSES VARY. THE SURGEON IDENTIFIED A REVIEW PUBLICATION NOTING THAT COLD MIGHT CONTRIBUTE TO THE DEVELOPMENT OF CRPS IN CERTAIN PTS, SO BELIEVED THAT IT IS POSSIBLE GAME READY USE IN BUNIONECTOMIES COULD LEAD TO CRPS. THIS PT WAS TREATED SUCCESSFULLY WITH SYMPATHETIC NERVE BLOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAME READY SYSTEM 890.5650 IRP ILO IRP COOLSYSTEMS, INC. 500055

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| S