UNKNOWN (NOT COMMUNICATED BY THE DISTRIBUTOR)

Description of Event or Problem

ON FEBRUARY 19, 2026, WE RECEIVED A CUSTOMER COMPLAINT FROM OUR DISTRIBUTOR (B)(4) IN THE UNITED STATES. THE DESCRIPTION OF THE INCIDENT IS AS FOLLOWS: PATIENT : (B)(6), SITE : (B)(6), PHYSICIAN : DR. (B)(6). INJURY : NO, PRODUCT BRAND : UNKNOWN, PRODUCT MODEL : UNKNOWN, SERIAL NUMBER : UNKNOWN, WAS THERE A CHANGE IN TREATMENT AS A RESULT OF THE EVENT? : NO. WE WERE INFORMED BY OUR PHYSICIAN THAT PATIENT (B)(6) HAD AN SEEG LEAD BROKEN UPON EXPLANT. SEEG IMPLANT DATE WAS (B)(6) 2025. THE LEAD WAS REMOVED SAFELY AFTER IT WAS DISCOVERED ON MRI POST EXPLANT. WE WERE NOT GIVEN ADDITIONAL BESIDES THIS. ON (B)(6) 2026, WE ASKED (B)(4) SOME FOLLOW-UP QUESTIONS AND RECEIVED A RESPONSE FROM THEM ON (B)(6) 2026: DIXI QUESTION: THE IMPLANTATION WAS PERFORMED ON (B)(6) 2025, AND THE ELECTRODE BREAKAGE WAS DETECTED FOLLOWING THE POST-EXPLANT MRI. COULD YOU PLEASE PROVIDE A TIMELINE OF EVENTS FROM IMPLANTATION UNTIL TODAY? (B)(4) ANSWER : WE WERE TOLD POST RNS IMPLANT THAT PATIENT HAS A BROKEN ELECTRODE FROM SEEG. DIXI QUESTION: WHAT WAS THE ELECTRODE SIGNAL QUALITY PRIOR TO EXPLANTATION? (B)(4) ANSWER: UNKNOWN. DIXI QUESTION: WOULD IT BE POSSIBLE TO SHARE THE MRI IMAGES WITH US? (B)(4) ANSWER: WE DO NOT HAVE MRI IMAGES. DIXI QUESTION: AT WHICH LOCATION DID THE ELECTRODE BREAK? (B)(4) ANSWER: IT WAS AN 8 CONTACT AND BROKE BETWEEN 7&8 UPON REMOVAL PER PHYSICIAN. DIXI QUESTION: WHERE WAS THE ELECTRODE IMPLANTED? (B)(4) ANSWER: UNKNOWN. DIXI QUESTION: WERE THERE ANY EXTERNAL EVENTS THAT COULD EXPLAIN WHY THE ELECTRODE BROKE? (B)(4) ANSWER : UNKNOWN.

Additional Manufacturer Narrative

ON FEBRUARY 19, 2026, WE RECEIVED A CUSTOMER COMPLAINT FROM OUR DISTRIBUTOR (B)(4)(DISTRIBUTOR) IN THE UNITED STATES. PATIENT : (B)(6), SITE : (B)(6), PHYSICIAN : DR. (B)(6), INJURY : NO, PRODUCT BRAND : UNKNOWN, PRODUCT MODEL : UNKNOWN, SERIAL NUMBER : UNKNOWN, WAS THERE A CHANGE IN TREATMENT AS A RESULT OF THE EVENT? : NO. WE DON'T HAVE ANYMORE INFORMATION. WE TRIED TO HAVE MORE INFORMATION BUT FOR THE MOMENT IT IS NOT CONCLUSIVE. NOTE : WE TRIED TO SUBMIT THIS REPORT ON TIME, BUT WE ENCOUNTERED TECHNICAL DIFFICULTIES AS WE WERE IN THE PROCESS. THE REPORTS ARE OUTSIDE THE 30-DAY INTERNAL REPORTING WINDOW BECAUSE DIXI MEDICAL WERE STILL IN THE ENROLLMENT PROCESS FOR ELECTRONIC SUBMISSION. WE THEN CONTACTED THE HELP DESK, WHICH ASSISTED US WITH THIS PROCESS.