BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAME READY SYSTEM

    MDR report key: 1060883 · Received June 13, 2008

    Report

    Report Number
    2954777-2008-00001
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    November 30, 2007
    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

    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 DESCRIBED, 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-USE DEVICE AND THERE WAS NO DEVICE 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 UNDERWENT BUNIONECTOMY SURGERY IN 2007 AND POST-OPERATIVE THERAPY WITH ELEVATION AND CRYOTHERAPY WITH GAME READY. THE PT DEVELOPED BRUISING ON THE TIP OF HER TOE THAT WAS NOTED 7 DAYS POST-SURGERY. AT 10 DAYS POST-SURGERY, SHE WAS FOUND TO HAVE CYANOSIS AND SEVERE SWELLING OF HER LOWER EXTREMITY, WHICH PROGRESSED TO TOE NECROSIS. SHE ALSO HAD CIRCUMFERENTIAL ANESTHESIA FROM THE LEVEL OF THE ANKLE TO THE TOES. THE SURGEON PERFORMED A 2ND SURGERY TEN DAYS LATER. THE PT SUBSEQUENTLY RESPONDED TO SYMPATHETIC NERVE BLOCKS AND HAD A PARTIAL AMPUTATION OF THE GREAT TOE BY PLASTIC SURGEON AND CONTINUED TO HEAL UNEVENTFULLY. THERE WAS NO REPORT OF DEVICE MALFUNCTION AND THE SURGEON CONSIDERED THIS A BAD OUTCOME OF THE SURGERY AND NOT A COMPLAINT OR ADVERSE EVENT ASSOCIATED WITH GAME READY. A BUNIONECTOMY PT DEVELOPED CLASSIC SYMPTOMS OF REFLEX SYMPATHETIC DYSTROPHY (RSD), ALSO KNOWN AS COMPLEX REGIONAL PAIN SYNDROME (CRPS). THE SURGEON CONCLUDED THAT THE TEN DAYS PRIOR TO ORIGINAL DATE PT MAY HAVE HAD RSD AND THAT POSSIBLY THE USE OF GAME READY HAD CONTRIBUTED TO THESE EVENTS. THE SURGEON WAS UNCERTAIN OF THE RELATIONSHIP TO OUR PRODUCT, SO ASKED OUR DISTRIBUTOR IF THERE WERE OTHER RSD CASES WITH GAME READY USERS. 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 CUSTOMERS BELIEVED HE 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.

    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 56 YR Hospitalization| S NEXIUM| PREMPRO| ATENOLOL