INT ADV 2CH COLOR COMBO W/EMG

Description of Event or Problem

POTENTIAL SERVICE OF SUMMONS AND COMPLAINT WAS MANUFACTURER'S FIRST NOTICE OF THIS EVENT. INCIDENT WITH INTELLECT MACHINE USING TENS: CHANNEL 2 SENT SURGE THROUGH PATIENT, THROUGH ARM, UP NECK, THROUGH RACING HEART AND TINGLING DOWN ARM. MACHINE IMMEDIATELY TURNED OFF AND AMBULANCE CALLED. PATIENT TAKEN TO HOSPITAL. IT IS UNKNOWN AT THIS TIME IF THE PATIENT REQUIRED HOSPITALIZATION. QUESTIONNAIRE SENT TO DISTRIBUTOR TO COMPLETE. IT WAS CONFIRMED PATIENT DOES NOT HAVE A PACEMAKER AND THIS WAS ASKED PRIOR TO COMMENCING TREATMENT. THE EVENT OCCURRED IN (B)(6). THE COMPANY HAS BEEN UNABLE TO INSPECT THE DEVICE. BECAUSE THE MATTER IS IN POTENTIAL LITIGATION, IT HAS BEEN TURNED OVER TO OUTSIDE COUNSEL FOR FURTHER INVESTIGATION.