SENSIGHT

Additional Manufacturer Narrative

H3: ANALYSIS OF THE SCREENING CABLE HAD SHOWN THAT THERE WAS DAMAGE AT THE DISTAL END. 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 THE MEASURING CABLE SHOWED IMPEDANCES WERE >40,000 OHM ON CONTACTS 2C AND 3. THERE WERE NO KNOWN CONTRIBUTING FACTORS. THE MEASURING CABLE WAS RECONNECTED, ROTATED, AND THE ELECTRODE WAS CLEANED SEVERAL TIMES BUT THE ISSUE PERSISTED. THE MEASURING CABLE WAS REPLACED WITH A NEW ONE, AFTER WHICH NO FURTHER ABNORMALITIES WERE FOUND, IMPEDANCES WITHIN THE NORMAL RANGE. THE ISSUE WAS RESOLVED. (B)(6) 2025 E1 (FOR, REP): NO NEW INFORMATION. (B)(6) 2025 E2 (REP, FOR) NO NEW INFORMATION (B)(6) 2025 AN_RP (FOR, REP); NO NEW INFORMATION.