PATHWAY

Description of Event or Problem

A HEALTHY VOLUNTEER SUBJECT WAS RECEIVING THERMAL HEAT STIMULATION TO HER RIGHT LOWER LEG. THE STIMULUS WAS DELIVERED BY THE PATHWAYS DEVICE, RISING FROM A BASELINE TEMP OF 35C TO A TARGET TEMP OF 48C, THE PT EXPERIENCED A BURN. ALTHOUGH THE SUBJECT WAS CONSCIOUS, NON-SEDATED, AND IN A LAB SETTING, WITH FREE ACCESS TO HER LEG, WHEN THE SUBJECT REMOVED THE PROBE, SHE HAD RECEIVED A SIGNIFICANT BURN IN THE STIMULATED REGION (16X16MM) OF SKIN. UPON INSPECTION, THERE WAS A BLISTER AND OBVIOUS SKIN DAMAGE TO THE 16X16MM REGION OF SKIN THAT WAS DIRECTLY CONTACTED BY THE STIMULATOR, WITH REDNESS AROUND THE PERIPHERY. ICE WAS APPLIED AND A PHYSICIAN OPINION INDICATED THAT THE BURN WAS GREATER THAN 2ND DEGREE AND PROVIDED THE SUBJECT WITH SILVADENE (SP) CREAM AND ANALGESICS. A FOLLOW-UP APPOINTMENT WAS ARRANGED WITH THE BURN CLINIC.

Additional Manufacturer Narrative

THE PATHWAY STIMULATOR HAS A FAILSAFE CUTOFF THAT IS ACTIVATED WHEN THE STIMULUS TEMP EXCEEDS A CERTAIN THRESHOLD (TYPICALLY 54C). IN THIS CASE IT APPEARS THAT THIS FAILSAFE PROCEDURE WAS ACTIVATED; HOWEVER, THE STIMULATOR MAY HAVE REMAINED ACTIVE/ON DESPITE THE FACT THAT THE SOFTWARE NOTIFICATIONS INDICATED THAT THE STIMULATOR WAS OFF. MEDOC VISITED THE INCIDENT SITE AND INVESTIGATED PROBLEM WITH THE REPORTED SYSTEM. THE SYSTEM WAS THEN CHECKED TWICE AND WAS FOUND TO MEET THE PERFORMANCE REQUIREMENTS IN THAT IT PASSED SELF TESTS AND SAFETY PROTOCOLS SUCCESSFULLY. NEVERTHELESS, MEDOC PERFORMED COMPREHENSIVE SERVICE ON THE SYSTEM IN ORDER TO RESTORE CUSTOMER CONFIDENCE. ALTHOUGH MEDOC COULD NO RE-CREATE THE CONDITION WHICH CAUSED THE SITUATION, HAD THE OPERATOR USED THE MANUAL BUILT IN SAFETY PANIC BUTTON, OR THE TEST SUBJECT (VOLUNTEER) WOULD HAVE USED THE EXTENDED PAIN BUTTON DURING THE INCIDENT, THE BURN COULD HAVE PREVENTED. MEANWHILE MEDOC CONSIDERS THIS TO BE AN ISOLATED EVENT IN THAT IT HAS HAD NO OTHER COMPLAINTS OF THIS NATURE AND REMAINS IN CLOSE CONTACT WITH ITS CUSTOMERS.