MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA IMPLANT; COCHLEAR IMPLANT

Model Number	CI-1600-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Meningitis (2389)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Event or Problem Description
The recipient is reportedly experiencing bacterial meningitis.The recipient is presenting with dizziness, headache and noise with and without device use.The recipient was prescribed corticosteroids and antibiotics (type unknown) on (b)(6) 2026.Advanced bionics is in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information section: advanced bionics considers the investigation into this reportable event as closed.The recipient's meningitis has reportedly resolved.The meningitis was not device related.The recipient has resumed use and remains implanted.Dizziness, headaches, and other symptoms were reportedly not related to device use.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES¿ ULTRA IMPLANT
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: ivvet perez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 24239946
• Report Number: 3006556115-2026-00126
• Device Sequence Number: 10229720
• Product Code: MCM
• UDI-Device Identifier: 07630016877988
• UDI-Public: (01)07630016877988(11)211109(17)241031
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2024
• Device Model Number: CI-1600-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female