NIM® EMG ELECTRODE

Description of Event or Problem

IT WAS REPORTED THAT DURING PAROTID SURGERY, NERVE STIMULATION (THOUGH VISIBLE/PALPABLE MUSCLE CONTRACTIONS OF THE FACE) DID NOT GET PICKED UP BY THE MONITOR. THE PATIENT WOKE UP WITH SOME DEGREE OF NERVE PALSY (WEAKNESS OF THE FACE). WEAKNESS OBSERVED WAS POST-OPERATIVELY. THE PAROTID PATIENT HAD A MARGINAL MANDIBULAR WEAKNESS. THE STIMULUS SET TO ON THE NIM VITAL CONSOLE FOR THE PAROTID WAS TURNED DOWN TO 0.3 WHICH IS STANDARDLY AS THERE IS QUITE A BIT OF STIMULATING WITH A PAROTID. THE THRESHOLD SET TO THE NIM VITAL CONSOLE WAS DEFAULT SETTING. STIMULUS PROBE WAS BEING USED TO ILLICIT THE EMG RESPONSE FROM THE FACIAL NERVE. DURING THE MUSCLE MOVEMENT, USER TURNED THE STIMULUS BACK UP TO THE DEFAULT SETTING, HOWEVER THERE WAS NO IMPROVEMENT. THE THRESHOLD WAS NOT TURNED DOWN WHEN THIS ISSUE OCCURRED. FACIAL PALSY IS AN INHERENT RISK OF PAROTID SURGERY. HOWEVER, BECAUSE THE STIMULATOR WAS NOT ELICITING A RESPONSE, COULDN'T TRUST IT AND HAD TO PRESUME EVERYTHING THAT LOOKED LIKE NERVE WAS NERVE. BUT THE USER HAVE TO CUT SOME STRUCTURES OTHERWISE THE MASS WOULD NEVER COME OUT. PATIENT RECEIVED ORAL STEROIDS, USER HAVE REFERRED THE PAROTID PATIENT FOR PHYSIO. THE PAROTID PATIENT HAS DEFINITELY IMPROVED, NOW A SUBTLE WEAKNESS, ABLE TO EAT/DRINK WITHOUT DROOLING, BUT NOT NORMAL (YET).

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Additional Manufacturer Narrative

H6:PREVIOUS CODE D16 IS NO LONGER VALID. CORRECTION :SECTION B WAS INCORRECTLY UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.