MICRODEEP DEPTH ELECTRODE D08-XXXM

Description of Event or Problem

ON APRIL 28, 2026, WE BECAME AWARE OF A PUBLICATION FROM LA TIMONE HOSPITAL IN MARSEILLE, FRANCE REPORTING A CASE OF ELECTRODE BREAKAGE THAT OCCURRED ON TWO ELECTRODES DURING THE SAME PROCEDURE. (SOURCE: HTTPS://WWW.RESEARCHGATE.NET/PUBLICATION/403331777_DELAYED_BRAIN_AND_SPINE_MIGRATION_OF_A_RETAINED_SEEG_ELECTRODE_FRAGMENT_AN_UNEXPECTED_COMPLICATION). SUMMARY OF THIS PUBLICATION: THE SEEG PROCEDURE WAS PERFORMED IN 2023. DURING THE PROCEDURE, A TOTAL OF 15 ELECTRODES WERE IMPLANTED, 11 ON THE LEFT SIDE AND 4 ON THE RIGHT SIDE. DURING MONITORING, THE PATIENT EXPERIENCED MULTIPLE SEIZURES. SIGNAL LOSS WAS OBSERVED ON 2 ELECTRODES THREE DAYS AFTER THE START OF RECORDINGS (BOTH BROKEN AND ON THE LEFT SIDE WHERE THERE WERE 11 ELECTRODES IMPLANTED). AT EXPLANTATION, THE ELECTRODES COULD NOT BE RECOVERED BECAUSE THE ACTIVE PART WERE NOT VISIBLE. POSTOPERATIVE MRI CONFIRMED THE PRESENCE OF 2 PARTS OF THE ELECTRODES. THESE PARTS WERE LEFT IN PLACE FOLLOWING THE SURGEON'S DECISION. NEARLY 3 YEARS AFTER SEEG IMPLANTATION (2026), THE PATIENT PRESENTED WITH PROGRESSIVE GAIT INSTABILITY AND FREQUENT FALLS. BRAIN IMAGING WAS INITIALLY PERFORMED AND SHOWED MIGRATION OF ONE ELECTRODE FRAGMENT INTO THE LEFT TEMPORAL HORN OF THE LATERAL VENTRICLE AND HAD CHANGED POSITION COMPARED TO PRIOR IMAGING. HOWEVER, SINCE TWO ELECTRODE FRAGMENTS WERE KNOWN TO BE RETAINED AND ONLY ONE WAS VISUALIZED INTRACRANIALLY, SPINAL IMAGING WAS PERFORMED. A LUMBAR SPINE X-RAY REVEALED A LINEAR, RADIOPAQUE FOREIGN OBJECT WITHIN THE SPINAL CANAL AT THE L4-L5 LEVEL. SURGERY WAS PERFORMED TO REMOVE THE FRAGMENT LOCATED BETWEEN L4 AND L5, WHICH WAS IDENTIFIED AS THE MIGRATED ELECTRODE. THE PATIENT STILL HAS ANOTHER RETAINED ELECTRODE FRAGMENT THAT HAS MIGRATED TOWARD THE TEMPORAL HORN. AT PRESENT, THIS FRAGMENT REMAINS ASYMPTOMATIC AND WILL BE MANAGED CONSERVATIVELY, WITH CONTINUED CLINICAL AND RADIOLOGICAL MONITORING AS PART OF ROUTINE EPILEPSY FOLLOW-UP. SHOULD FURTHER MIGRATION OR SIGNS OF COMPLICATION OCCUR, SURGICAL RETRIEVAL WILL BE RECONSIDERED. UPON BECOMING AWARE OF THE EVENT THROUGH THE PUBLICATION, DIXI MEDICAL CONTACTED THE CUSTOMER: QUESTIONS TO GATHER DETAILED INFORMATION ABOUT THE INCIDENT ON APRIL 28, 2026, WE REQUESTED INFORMATION FROM THE SURGEONS TO AID IN THE ANALYSIS OF THE COMPLAINT AND TO HELP DETERMINE THE CAUSE OF THE INCIDENT: "HERE IS THE LIST OF QUESTIONS: FOR ELECTRODE WITH MIGRATED FRAGMENT - ELECTRODE REFERENCE AND SERIAL NUMBER - NUMBER OF ELECTRODE CONTACTS - REFERENCE AND SERIAL NUMBER OF THE GUIDING SCREW - IS THE ELECTRODE AVAILABLE FOR RETURN AND ANALYSIS? FOR ELECTRODE WITH RETAINED FRAGMENT - ELECTRODE REFERENCE AND SERIAL NUMBER - NUMBER OF ELECTRODE CONTACTS - REFERENCE AND SERIAL NUMBER OF THE GUIDING SCREW - IS THE ELECTRODE AVAILABLE FOR RETURN AND ANALYSIS? ABOUT THE EVENT - DATE OF IMPLANTATION - DATE OF EXPLANTATION - WERE ANY SEIZURES OBSERVED DURING THE FIRST THREE DAYS? - WAS THE EVENT REPORTED TO YOUR LOCAL VIGILANCE/INCIDENT REPORTING SYSTEM? DOCUMENTS TO HELP US INVESTIGATE THE POSSIBLE CAUSES LEADING TO THE FRACTURE OF THESE TWO ELECTRODES, COULD YOU PLEASE PROVIDE: - THE IMPLANTATION PLAN - POSTOPERATIVE CT FOR ANALYSIS (DICOM OR NIFTI FORMAT)". FOLLOW-UP OF THIS QUESTIONS: - ON MAY 6, 2026, HAVING RECEIVED NO RESPONSE FROM THE SURGEONS, WE FOLLOWED UP ON THE PREVIOUS EMAIL AND REQUESTED A VIDEO MEETING. - ON MAY 21, 2026, HAVING RECEIVED NO RESPONSE FROM THE SURGEONS, WE FOLLOWED UP ON THE PREVIOUS EMAIL AND REQUESTED A VIDEO MEETING.

Additional Manufacturer Narrative

DIXI MEDICAL IS AWAITING A RESPONSE FROM THE CUSTOMER REGARDING THE REQUESTED INFORMATIONS. TO DATE, WE HAVE NOT RECEIVED ANY INFORMATION CONCERNING THE PRODUCT INVOLVED OR THE CIRCUMSTANCES OF THE INCIDENT. THESE ELEMENTS ARE ESSENTIAL FOR DETERMINING THE ROOT CAUSES THAT LED TO THE INCIDENT. A FOLLOW-UP WAS SENT ON MAY 6, AND THEN MAY 21, BUT NO RESPONSE HAS BEEN RECEIVED TO DATE FROM THE CUSTOMER. NOTE: WE SUBMIT THIS REPORT ON TIME, BUT WE ENCOUNTERED TECHNICAL DIFFICULTIES AS WE RECEIVE THE FOLLOWING ERROR MESSAGE: "ONLY ONE PMA/510(K) IS ALLOWED PER REPORT." WE HAVE REVIEWED AND CONFIRMED THAT THE PMA/510(K) NUMBER IS CORRECT; HOWEVER, WE ARE STILL UNABLE TO COMPLETE THE SUBMISSION, EVEN AFTER A SECOND ATTEMPT. THE REPORTS ARE OUTSIDE THE 30-DAY INTERNAL REPORTING WINDOW, WE CONTACTED THE HELP DESK, WHICH ASSISTED US WITH THIS PROCESS.