Description of Event or Problem · 1
IT WAS REPORTED TO MANUFACTURER THAT WHEN THE VNS PATIENT'S DEVICE WAS TESTED AT A ROUTINE FOLLOW UP VISIT, A NORMAL MODE DIAGNOSTIC TEST WAS NOT ABLE TO BE PERFORMED SUCCESSFULLY. IT WAS REPORTED THAT PRIOR TO PERFORMING THE NORMAL MODE TEST, A SYSTEM DIAGNOSTIC TEST WAS PERFORMED AND REVEALED NORMAL DEVICE FUNCTION AND THE END OF SERVICE STATUS WAS NO. AFTER THE SYSTEM DIAGNOSTIC TEST WAS PERFORMED, A NORMAL MODE TEST WAS ATTEMPTED, HOWEVER THE TEST REVEALED THE FOLLOWING: OUTPUT STATUS =, OUTPUT CURRENT =, LEAD IMPEDANCE = UNK. THE TEST WAS ATTEMPTED TWICE WITH THE SAME RESULT EACH TIME. IT WAS REPORTED THAT THE PT DEVICE SETTINGS WERE PROGRAMMED TO THE MINIMUM REQUIRED SETTINGS TO SUCCESSFULLY PERFORM THE NORMAL MODE TEST. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL TO DATE.