NIM® EMG ELECTRODE

Description of Event or Problem

IT WAS REPORTED THAT THE BLUE CORD OF THE DEVICE DID NOT RESPOND DURING PAROTID GLAND SURGERY. PROCEDURE COMPLETED WITH BACK UP PRODUCTS. NO PATIENT IMPACT.

Additional Manufacturer Narrative

THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. H3: PRODUCT ANALYSIS FOUND VISUALLY, ONE OF THE NEEDLE PINS WAS MARGINALLY BENT. UNDER MAGNIFICATION, THERE WAS DISCOLORATION ON THE DISTAL TIP OF ONE OF THE NEEDLES. ELECTRICALLY, THE RESISTANCE FROM END TO END OF A BLUE PAIRED ELECTRODE SHALL BE LESS THAN 2.0 OHMS AND THE ACTUAL MEASUREMENTS BETWEEN BOTH POLES WERE 1.7 AND 1.9 OHMS WHICH WAS IN SPECIFICATION. HOWEVER, THERE WAS A CONTINUITY READING ON OPPOSITE POLES (OPEN CIRCUIT). 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.