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 Code	Unspecified Infection (1930)
Date of Event	01/16/2026
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 reportedly experienced an infection.The recipient's device was explanted.Advanced bionics is still in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: sections b.3, d.6b, & h.6.The recipient's device was explanted.The recipient will not be re-implanted.The wound healed.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.Bipolar cautery was reportedly used during the surgery.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
Correction information: sections h.4, h.10.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 believed to be related to the return reason and is believed to have occurred post revision surgery.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 IMPLANT
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: rita nicholson ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 24209285
• Report Number: 3006556115-2026-00109
• Device Sequence Number: 13168010
• Product Code: MCM
• UDI-Device Identifier: 07630016828638
• UDI-Public: (01)07630016828638(11)150319(17)171231
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 01/26/2026

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: 12/31/2017
• 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
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/25/2026; 05/08/2026; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2015
• 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 Sex: Female