NIM® EMG ELECTRODE

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.

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE, THE NIM INTERFACE BOX FELL OFF THE BED AND THERE WAS WHAT APPEARED TO BE A SHOCK TO THE PATIENT THAT HAD THE UPPER TORSO AND HEAD AREA SHOOT UP IN BED. THE REST OF THE PROCEDURE WAS CONTINUED AFTER THE INCIDENT, THE NIM VITAL SEEMED TO BE WORKING NORMALLY AFTER THE ¿SHOCK¿ OCCURRENCE. THERE WAS NO KNOWN PATIENT IMPACT.