NIM® EMG ELECTRODE

Additional Manufacturer Narrative

H3: THERE WERE 4 ELECTRODES (RED/WHITE, GREEN, RED PAIRED ELECTRODE AND BLUE PAIRED ELECTRODE) RETURNED IN A TRIPLE RESEALABLE BAG. UPON RETURN, THERE WERE NO TRACES OF BIOLOGICAL CONTAMINATION OBSERVED ON THE ELECTRODES. THERE WAS NO DAMAGE NOTED IN THE CONSTRUCTION OF THE RETURNED ELECTRODES. WHEN RETURNED, ALL ELECTRODES¿ NEEDLES WERE EXPOSED AND NOT PROTECTED WITH WHITE FOAM/SPONGE. ELECTRICALLY, THE RESISTANCE FROM END TO END SHALL BE 2 OHMS, AND MEASUREMENTS WERE: RED/WHITE ELECTRODE 1.5 OHMS, GREEN ELECTRODE 1.0 OHMS, BLUE PAIRED ELECTRODE 1.7 OHMS AND 1.9 OHMS, AND RED PAIRED ELECTRODE 1.7 OHMS AND 45 OHMS. ALL ELECTRODES HAD RESISTANCE WITHIN SPECIFICATION EXCEPT RED PAIRED ELECTRODE THAT HAD HIGHER RESISTANCE THAN 2 OHMS. IN THE RETURNED CONDITION, ALTHOUGH THERE WAS AN OUT OF SPECIFICATION CONDITION FOUND DURING THE ANALYSIS, THERE WAS NO OUT OF SPECIFICATION CONDITION FOUND THAT WAS RELATED TO THE COMPLAINT AS THE INCREASE IN RESISTANCE IS MOST LIKELY ATTRIBUTABLE TO POST-MANUFACTURING FACTORS SUCH AS CLINICAL USE, HANDLING, OR ENVIRONMENTAL EXPOSURE AND THIS READING WOULD NOT CAUSE A SKIN TAP TEST WITH NO RESPONSE. THE COMPLAINT WAS NOT CONFIRMED DUE TO NO OUT OF SPECIFICATION CONDITION OBSERVED RELATED TO THE COMPLAINT. H6: CODES ARE UPDATED. PREVIOUSLY APPLIED FDM B21, FDR C21, FDC D16 CODES NO LONGER APPLICABLE.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.

Additional Manufacturer Narrative

H3 - EVALUATION OF THE RETURNED DEVICE WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT 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.

Description of Event or Problem

IT WAS REPORTED THAT PRE OP SURGEON HAVE MENTIONED THE ELECTRODE NOT FUNCTIONING AFTER CONNECTED TO PATIENTS INTERFACE. NO READINGS AFTER TAPPING THE SKIN SIMULTANEOUSLY, THEY OPEN ANOTHER ELECTRODE TO PROCEED WITH THE SURGERY. THERE WAS NO PATIENT IMPACT.