NIM® EMG ELECTRODE

Additional Manufacturer Narrative

H3: VISUALLY, THE NEEDLE PINS ON THE RED AND BLUE PAIRED ELECTRODES WERE BENT WHEN RETURNED. THERE WAS A REDDISH-BROWN RESIDUE ON THE NEEDLE TIPS. ELECTRICALLY, THE RESISTANCES FROM END TO END FOR RED AND BLUE PAIRED ELECTRODES SHALL BE LESS THAN 2.0 OHMS AND THE ACTUAL MEASUREMENTS WERE 1.1 AND 1.6 OHMS BETWEEN BOTH POLES (BLUE) AND 1.6 AND 1.0 OHMS BETWEEN BOTH POLES (RED) WHICH WERE IN SPECIFICATION. THE RESISTANCE FROM END TO END FOR GREEN AND RED/WHITE SUBDERMAL ELECTRODES SHALL BE LESS THAN 2.0 OHMS AND THE ACTUAL MEASUREMENTS WERE 1.0 OHMS (GREEN) AND 1.3 OHMS (RED/WHITE) WHICH WERE IN SPECIFICATION. IN THE RETURNED CONDITION, THERE WAS NO OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. H6: CODES ARE UPDATED. PREVIOUSLY APPLIED FDM B17, FDR C20, FDC D16 CODES NO LONGER APPLICABLE. 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

ADDITIONAL INFORMATION RECEIVED THE SAME NIM WAS USED TO COMPLETE THE PROCEDURE.

Additional Manufacturer Narrative

B5: ADDITIONAL INFORMATION RECEIVED. 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 BEGINNING OF CASE CHANNEL 2 WAS CONSTANTLY GOING OFF AND BEEPING. USER SWAPPED OUT THE NIM VITAL FOR THE SECOND NIM VITAL AND THE PROBLEM PERSISTED. THE DEVICE WAS WORKING NORMALLY WHEN REP CHECKED. THERE WAS NO 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.