Description of Event or Problem · 0
PATIENT WAS IMPLANTED WITH ADVANCED BIONICS HIRES ULTRA 3D CI (V1 SERIES) COCHLEAR IMPLANT ((B)(6)) IN (B)(6) OF 2018. IMPLANT WAS INCLUDED IN THE POSSIBLE DEVICE FAILURE COHORT OF ADVANCED BIONICS ELECTRODE ARRAYS. PATIENT RECEIVED A LETTER IN (B)(6) OF 2020 STATING HIS IMPLANT WAS INCLUDED IN THE POTENTIAL DEVICE FAILURE BATCH OF ELECTRODES. PATIENT HAS BEEN ON A THREE-MONTH FOLLOW-UP PLAN SINCE TO MONITOR THE INTERNAL ELECTRODE. HE WAS SEEN (B)(6) 2024 FOR MONITORING. ON THIS DATE, IT WAS NOTED HIS ELECTRODE IMPEDANCES WERE LOW ON 4-5 ELECTRODES WHICH WAS A RED FLAG/MARKER OF A DEVICE FAILURE IN THESE ELECTRODES. ELECTRODES THAT WERE FLAGGED WERE NUMBERS 12-15 POSSIBLY 16. ELECTRODE 11 SHOWED A DECLINE, BUT NOT SIGNIFICANT ENOUGH TO INDICATE A FAILURE AT THIS TIME. NEURAL RESPONSE IMAGING (NRI) WAS COMPLETED ACROSS THE ENTIRE ELECTRODE ARRAY. RESPONSES FOR ELECTRODES 12-16 INDICATED NO RESPONSES WITH HIGH EP GROWTH FUNCTION VALUES AT OVER 600-2000 MICROVOLTS. THESE MEASUREMENTS ARE TYPICALLY WITHIN THE 100-200 MICROVOLT RANGE. RESPONSES IN THE 600 MICROVOLT RANGE ARE ANOTHER MARKER FOR A DEVICE ISSUE. DOCUMENTATION FROM THE COMPANY, ADVANCED BIONICS, STATES THAT THE DEVICE FAILURE INDICATIONS FOR THIS IMPLANT ARE: SIGNIFICANT IMPEDANCE DROPS (E.G. 50%) TO LEVELS BELOW 3.5 KOHMS ON 4 OR MORE ELECTRODES - AFFECTED ELECTRODES ARE TYPICALLY ON THE BASAL END OF THE ARRAY (E.G. 13-16) - NRI RESPONSES REDUCED OR ABSENT DUE TO CHANGE IN IMPEDANCES AND STIMULUS DELIVERY. - CHANGE IN AUDIBILITY AND/OR LOUDNESS GROWTH ON THE EFFECTED ELECTRODES - REDUCED ABILITY TO HEAR HIGH PITCHED SOUNDS (FOR EXAMPLE, "F" OR "S" SOUNDS) OBJECTIVE MEASURES INDICATE THIS IS A DEVICE FAILURE. THESE INCLUDE IMPEDANCE VALUES AND NRI RESPONSES OBTAINED. PATIENT COMPLETED SOUNDFIELD TESTING TO INCLUDE AIDED DETECTION. HISTORICALLY, PATIENT HAS HAD AIDED DETECTION THRESHOLDS WITHIN THE NORMAL HEARING THRESHOLD RANGE. ON (B)(6) 2024, PATIENT HAD NO RESPONSES AT 3000-6000 HZ. THESE CORRESPOND TO THE SAME ELECTRODES THAT HAVE BEEN AFFECTED ON OBJECTIVE TESTING. COMPANY REPRESENTATIVE WAS CONTACTED AND CONFIRMED THIS WAS A DEVICE FAILURE. THEY RECOMMENDED THE IMPLANT BE EXPLANTED AND REPLACED. PATIENT IS GERIATRIC AND HAS HEALTH ISSUES THAT WOULD KEEP HIM FROM HAVING AN ELECTIVE SURGERY. IF THE PATIENT WERE TO BE EXPLANTED, THE FDA PAPERWORK WOULD HAVE BEEN COMPLETED AT THAT TIME. SINCE THE PATIENT CANNOT BE EXPLANTED, THIS REPORT WAS FILED.