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Patient 1
THE DEVICE WAS EVALUATED AND PASSED FUNCTIONAL TESTING. IT IS NOT KNOWN IF THE PATIENT HAD A HISTORY OF CHRONICALLY COMPRESSED NERVES. IT IS NOT KNOWN IF THE SURGEON ALLOWED SUFFICIENT TIME FOR THE DEVICE'S POSITIONING SYSTEM TO DETECT NERVE TISSUE PROPERLY. THE ROOT CAUSE OF THIS REPORTED EVENT HAS NOT BEEN DETERMINED. LABELING REVIEW: "PRECAUTION: THE NVM5? SYSTEM IS TO BE USED ONLY AS AN ADJUNCT TO MEDICAL JUDGMENT AND APPROPRIATE SURGICAL PRACTICES. DILATOR INSERTION AND ADVANCEMENT SHOULD BE CONDUCTED ONLY AFTER CAREFUL ANALYSIS OF RADIOGRAPHIC IMAGES OF THE OPERATIVE TARGET AREA. WHILE A POSITIVE EMG DETECTION BY THE NVM5 SYSTEM CAN BE ASSOCIATED WITH A HIGH LEVEL OF CERTAINTY THAT A NERVE IS IN CLOSE PROXIMITY TO THE DILATOR TIP, THE ABSENCE OF SUCH AN EMG DETECTION CANNOT BE CONSTRUED AS A CERTAIN INDICATION THAT NO NERVES ARE CLOSE TO THE DILATOR TIP. DO NOT ADVANCE DILATOR PROBES UNTIL ALL AVAILABLE DATA HAVE BEEN CONSIDERED. " "PRECAUTION: DO NOT ADVANCE THE DILATOR FASTER THAN THE RATE OF UPDATE OF DETECTION DATA." "WARNING: CHRONICALLY COMPRESSED NERVES, OR SEVERELY COMPRESSED NERVES IN AN ACUTE SETTING, ARE KNOWN TO BE LESS SENSITIVE TO DEPOLARIZATION CURRENTS (I.E., HAVE SIGNIFICANTLY HIGHER DEPOLARIZATION CURRENT VALUES). THEY ARE ALSO LESS LIKELY TO DEMONSTRATE SIGNIFICANT CHANGES IN THEIR THRESHOLD DEPOLARIZATION CURRENT VALUES IMMEDIATELY FOLLOWING NERVE DECOMPRESSION. UNDER SUCH CIRCUMSTANCES, EXERCISE CAUTION IN INTERPRETING DISPLAYED DATA."