NIM® EMG ELECTRODE

Additional Manufacturer Narrative

H3: VISUALLY, THERE WAS NO DAMAGE IN THE CONSTRUCTION OF THE DEVICES (FOUR ELECTRODES RETURNED INSIDE THE ONE C ARTON SAMPLE). ELECTRICALLY, THE RESISTANCE OF THE RED AND BLUE PAIRED SUBDERMAL ELECTRODES SHALL BE LESS THAN 2.0 OHMS, AND THE ACTUAL MEASUREMENTS WERE 1.8 AND 1.2 OHMS (BOTH POLES OF THE RED ELECTRODE) AND 1.3 AND 1.4 OHMS (BOTH POLES OF THE BLUE ELECTRODE) WHICH WERE IN SPECIFICATION. THE RESISTANCE OF THE GREEN GROUND AND RED/WHITE STIM ELECTRODES SHALL BE LESS THAN 2.0 OHMS, AND THE ACTUAL MEASUREMENTS WERE 0.95 OHMS (GREEN) AND 0.87 OHMS (RED/WHITE) WHICH WERE IN SPECIFICATION. THERE WAS NO INTERMITTENT BEHAVIOR WHILE MANIPULATING THE WIRES OR CONNECTORS ON ANY OF THE DEVICES. IN THE RETURNED CONDITION, THERE WAS NO OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. H6: CODES ARE UPDATED. PREVIOUSLY SUBMITTED FDM B21, FDR C21 AND FDC D16 ARE NO MORE 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

IT WAS REPORTED THAT DURING PROCEDURE WITH THE CORRECT PROCEDURE THE ELECTRODE HAS NO SIGNAL AND SOMETIMES WAS NORMAL. AUDIO SOMETIMES IS NORMAL, IT WAS UNSTABLE. THE PROCEDURE WAS COMPLETED USING BACK UP PRODUCTS. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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.