Description of Event or Problem · 0
I AM SUBMITTING THIS COMPLAINT REGARDING MED-EL CORPORATION'S FAILURE TO PROVIDE TIMELY CONTINUITY OF CARE FOR MY DAUGHTER, A PEDIATRIC COCHLEAR IMPLANT RECIPIENT, WHOSE EXTERNAL PROCESSORS HAVE NOW BEEN DECLARED OBSOLETE WITHOUT A MEDICALLY APPROPRIATE TRANSITION PATHWAY. COCHLEAR IMPLANT SYSTEMS ARE FDA-REGULATED CLASS III MEDICAL DEVICES. MED-EL IS THE SOLE MANUFACTURER RESPONSIBLE FOR SUPPORTING MY DAUGHTER'S INTERNAL IMPLANT AND THE ONLY ENTITY CAPABLE OF PROVIDING COMPATIBLE EXTERNAL PROCESSORS. AS SUCH, MED-EL HOLDS A NON-DELEGABLE OBLIGATION UNDER FDA POST-MARKET SURVEILLANCE, QUALITY SYSTEM REGULATION (21 CFR PART 820), AND MEDICAL DEVICE REPORTING (21 CFR PART 803) REQUIREMENTS TO ENSURE UNINTERRUPTED ACCESS TO FUNCTIONAL HEARING TECHNOLOGY. DESPITE MY SUBMISSION OF UPGRADE DOCUMENTATION ON NOVEMBER 5, 2025, MED-EL FAILED TO PROCESS THE ORDER IN A TIMELY MANNER. I WAS NOT NOTIFIED OF ANY DEFICIENCIES IN THE SUBMISSION FOR SEVERAL MONTHS. I HAVE NOW BEEN INFORMED THAT MED-EL IS INITIATING AN ENTIRELY NEW ORDER AFTER ALLOWING MY DAUGHTER'S PROCESSORS TO BECOME OBSOLETE, RESULTING IN A PREVENTABLE INTERRUPTION OF AUDITORY ACCESS FOR AN IMPLANTED PEDIATRIC PATIENT. ADDITIONALLY, MED-EL CONTACTED CLINICIANS WHO HAVE NEVER EVALUATED OR TREATED MY DAUGHTER INSTEAD OF COMMUNICATING DIRECTLY WITH ME OR HER MANAGING PROVIDERS. THIS REPRESENTS A BREAKDOWN IN MANUFACTURER COMPLAINT HANDLING, PATIENT FOLLOW-UP, AND CONTINUITY-OF-CARE OBLIGATIONS. THIS DELAY AND FAILURE TO PROVIDE TIMELY ACCESS TO A FUNCTIONAL EXTERNAL PROCESSOR PLACES MY DAUGHTER AT MEDICAL, EDUCATIONAL, AND DEVELOPMENTAL RISK. LOSS OF AUDITORY ACCESS FOR A PEDIATRIC COCHLEAR IMPLANT RECIPIENT CONSTITUTES A FORESEEABLE AND PREVENTABLE PATIENT HARM SCENARIO. I AM REQUESTING THAT THE FDA REVIEW MED-EL'S HANDLING OF THIS CASE UNDER: MEDICAL DEVICE REPORTING (21 CFR PART 803); POST-MARKET SURVEILLANCE (21 CFR PART 822); QUALITY SYSTEM REGULATION (21 CFR PART 820); COMPLAINT HANDLING AND CAPA REQUIREMENTS; OBSOLETE DEVICE TRANSITION AND PATIENT ACCESS OBLIGATIONS I AM REQUESTING CONFIRMATION THAT THIS COMPLAINT HAS BEEN LOGGED AND THAT APPROPRIATE REGULATORY REVIEW AND CORRECTIVE ACTION WILL BE INITIATED. PLEASE CONTACT ME IF ADDITIONAL DOCUMENTATION IS REQUIRED. SINCERELY, (B)(6), AUD DOCTOR OF AUDIOLOGY. PT CODE: 1881. DEVICE CODE: 3005. REFERENCE REPORT# MW5182554.