Description of Event or Problem · 1
HAD A NERVE CONDUCTION STUDY ON NEUROMAX CE 1004 DEVICE SERIAL NUMBER (B)(4) MADE BY XLTEX./NATUS CORP. THE MACHINE WAS REFURBISHED AND RECEIVED IN THE WAKE NEUROLOGY OFFICE IN (B)(6) LATE (B)(6) 2012. I WAS ONE OF THE FIRST PTS TO HAVE A NERVE CONDUCTION STUDY ON THIS MACHINE. I COMPLAINED OF PAIN FROM THE SHOCKS ON EVERY NERVE OF ARMS AND LEGS. SINCE THEN, I HAVE CONSTANT NERVE PAIN IN LEGS AND ARMS IN MULTIPLE NERVES, AND SEVERE BURNING NERVE PAIN AT NIGHT, ESPECIALLY IN MY LEGS. I REPORTED THIS FROM THE 1ST DAY OF THE TEST AND HAVE BEEN SUFFERING WITH PAIN FOR OVER 2 MONTHS. I HAVE BEEN OUT OF WORK SINCE THIS TEST AND HAVE BEEN GIVEN LIMITED INFO REGARDING IF THIS MACHINE WAS EVER TESTED FROM A QA PERSPECTIVE BEFORE IT WAS SHIPPED TO THE DOCTOR'S OFFICE. I HAVE BEEN SHUT-DOWN BY THE MFR REGARDING ANY INFO ABOUT THIS PARTICULAR MACHINE, INCLUDING ANY PAST POTENTIAL COMPLAINTS FROM PTS FROM THE PREVIOUS OWNER OF THE MACHINE, TO ANY PT COMPLAINTS FROM PTS TESTED BY MY DOCTOR ON THIS MACHINE. THIS WEEK, I FOUND OUT THE MACHINE WAS SHIPPED BACK TO THE MFR BUT HAVE NO INFO AS TO WHAT THEY WILL FIND, IF THEY PLAN ON TESTING IT, IF THEY CAN PULL THE VOLTAGES ACTUALLY USED FROM MY TEST, ETC. DATES OF USE: (B)(6) 2013 -- (B)(6) 2013. REASON FOR USE: TEST NERVES FOR NEUROPATHY.