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

Model Number	CI-1500-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling/ Edema (4577); Medical device site infection (4845); Cholesteatoma (4920)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The recipient reportedly experienced an infection.The recipient's device was explanted.Advanced bionics is in the process of gathering further information; once more information is obtained a supplemental report will be submitted.
Additional Manufacturer Narrative
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
Additional information: section b.3, d.6b, h.6, a.1, a.2, a.3, d.1, d.4, d.6a, h.4 & h.10.Correction information: section b.3, d.6b, h.6, a.1, a.2, a.3, d.1, d.4, d.6a, h.4 & h.10.The recipient's device was explanted.The recipient experienced reoccurring skin flap infection.The recipient presented with pus & swelling near headpiece site.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
Additional information: section d.9.The recipient has healed.The recipient will be re-implanted at a later time.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
The recipient reportedly experienced purulent material and bio film around the implant bed.The recipient reportedly experienced a cholesteatoma matrix in the middle ear and mastoid cavity.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 device passed external visual inspection and the photographic imaging inspection.System lock could not be obtained at any spacing.This is not related to the return reason.An electrical test could not be performed due to the system lock.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.However, lock could not be obtained.This is not related to the return reason.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
• 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: 22820119
• Report Number: 3006556115-2025-01173
• Device Sequence Number: 5713193
• Product Code: MCM
• UDI-Device Identifier: 07630016828638
• UDI-Public: (01)07630016828638(11)150827(17)180731
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/09/2025

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: 07/31/2018
• 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: 08/15/2025
• Supplement Report FDA Received Date: 09/11/2025; 10/07/2025; 10/07/2025; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2015
• 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: 14 YR
• Patient Sex: Male