NIM® EMG ELECTRODE

Description of Event or Problem

IT WAS REPORTED THAT VITAL GIVES INCONSISTENT ALARM WHEN TESTING ELECTRODES USING THE ANESTHESIOLOGIST' S TRAIN OF FOUR TRANSCUTANEOUSLY. FACE MOVING COULD BE SEEN BUT THE ALARM USUALLY DOESN'T SOUND. DOES NOT SOUND WHEN THE PATIENT AROUSES DURING SURGERY - EVEN WHEN TRYING TO SIT UP. DOES NOT SOUND WHEN SITE MECHANICAL EXPOSE OR TOUCH THE NERVE DOES NOT SOUND WHEN SITE PULL THE ELECTRODES OUT AT THE END OF THE CASE. THERE WAS NO KNOWN PATIENT IMPACT.

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.