NIM® EMG ELECTRODE

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS OF THE DEVICE FOUND THAT VISUALLY, THERE WAS NO DAMAGE IN THE CONSTRUCTION OF THE DEVICES. PER THE DRAWING, A 4-CHANNEL CASE PACK CONTAINS RED-, BLUE-, ORANGE-, AND VIOLET-COLORED PAIRED ELECTRODES. THE OPENED SAMPLE CONTAINED THE BLUE AND RED ELECTRODES AND THE VIOLET AND ORANGE SAMPLE WAS STILL SEALED BUT WAS OPENED FOR FURTHER ANALYSIS. ELECTRICALLY, THE RESISTANCE FROM END TO END OF THE PAIRED ELECTRODES SHALL BE LESS THAN 2.0 OHMS AND THE ACTUAL MEASUREMENTS WERE 1.6/1.8 OHMS (BLUE), 1.5/1.7 OHMS (RED), 1.7/1.7 OHMS (VIOLET), AND 1.6/1.6 OHMS (ORANGE). THE RESISTANCE FROM END TO END FOR THE SINGLE ELECTRODES SHALL BE LESS THAN 2.0 OHMS AND THE ACTUAL MEASUREMENTS WERE 1.5 OHMS (GREEN) AND 1.3 OHMS (RED/WHITE). THERE WERE NO SHORT CIRCUITS IN ANY OF THE ELECTRODES AND ALL ELECTRODES WERE IN SPECIFICATION. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 COCHLEAR IMPLANT PROCEDURE WHEN THE DOCTOR USED THE PROBE TO DETECT NERVE AND THE STIM RETURN SHOWED 1.5MA, BUT FOUND THERE WAS NO WAVEFORM ON NIM. THE DOCTOR TRIED TO CHECK STIM RETURN, FUSE AND ELECTRODE CHECK AND ALL OF THE ABOVE WERE NORMAL. SO, THE DOCTOR THOUGHT THE PROBLEM WAS PAIRED SUBDERMAL ELECTRODES. THERE WAS NO PATIENT IMPACT.