NIM® EMG ELECTRODE

Additional Manufacturer Narrative

PRODUCT ANALYSIS FOUND THAT THERE WAS NO EXTERNAL DAMAGE IN THE CONSTRUCTION OF THE DEVICES. ELECTRICALLY, THE RESISTANCE FROM END TO END SHALL BE LESS THAN 2.0 OHMS AND THE ACTUAL MEASUREMENTS WERE 1.9 OHMS BETWEEN BOTH POLES (BLUE) AND THERE WAS CONTINUITY BETWEEN BOTH POLES REGARDLESS OF WHICH PIN CONNECTOR WAS BEING TESTED (VIOLET) WHICH THE VIOLET ELECTRODES WERE OUT OF SPECIFICATION. FOR FURTHER ANALYSIS, AN X-RAY WAS PERFORMED TO OBSERVE THE INTERNAL CONSTRUCTION OF THE VIOLET PAIRED ELECTRODES AND THE CONNECTIONS INSIDE THE NEEDLE ELECTRODE WERE TOUCHING (ELECTRICAL SHORT) ¿ THERE WAS NO DAMAGE OR DEFECTS WITH THE INTERNAL CONSTRUCTION OF THE BLUE PAIRED ELECTRODES. IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. 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 THERE WAS NO RESPONSE; IMPEDANCE CHECK WAS OK; IT RESPONDED WHEN A REPLACEMENT PRODUCT CAME OUT. NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

H6: ADDITIONAL INFORMATION SUGGEST THAT D16 NO LONGER APPLY TO THIS EVENT. 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.