MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K ADVANTAGE¿ IMPLANT; COCHLEAR IMPLANT

Model Number	CI-1500-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Infectious Otitis Externa (4814); Medical device site infection (4845); Cholesteatoma (4920)
Date of Event	11/12/2025
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 was reportedly a non-user of the device due to cognitive impairment.The recipient presented with multiple episodes of infection (middle ear otitis) and developed a cholesteatoma.The recipient's device was explanted.The recipient was not reimplanted.The recipient is recovering well.
Additional Manufacturer Narrative
Additional information: section d.9.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
The external visual inspection revealed the electrode was sliced.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed broken electrode wires.System lock was verified.The condition of the electrode caused several channels to be out of range the device passed the electrical tests performed.The device passed the mechanical test performed.This device was explanted for medical reasons.The device passed the tests performed.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
Additional information: section h.6.Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly healed.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
Correction information: section h10/h.1.The external visual inspection revealed the electrode was sliced.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed broken electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The condition of the electrode caused several channels to be out of range the device passed the electrical tests performed.The device passed the mechanical test performed.This device was explanted for medical reasons.The device passed the tests performed.This older device configuration is no longer manufactured.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 90K ADVANTAGE¿ IMPLANT
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: lacey o'linn ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 23757944
• Report Number: 3006556115-2025-01635
• Device Sequence Number: 10170439
• Product Code: MCM
• UDI-Device Identifier: 07630016828638
• UDI-Public: (01)07630016828638(11)160311(17)190131
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/18/2025

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: 01/31/2019
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 04/08/2026; 05/05/2026; 05/29/2026; 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2016
• 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: 13 YR
• Patient Sex: Female