MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA 3D IMPLANT; COCHLEAR IMPLANT

Model Number	CI-1601-04
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Pain (1994); Wound Infection (2447); Fluid Discharge (2686); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The recipient reportedly experienced pain and swelling at the implant site.A shocking sensation was also noted with and without device use.2 rounds of antibiotics were prescribed without resolve.The recipient has an unspecified cochlear malformation.Device testing revealed results within normal limits.Improvement was noted with a 3rd round of antibiotics, steroids, and programming adjustments.The recipient presented with headaches and drainage.
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.The recipient's device was explanted.The recipient was not re-implanted at this time.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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: h.6.Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly developed drainage, samples were taken and the area was reportedly aspirated prior to explant surgery.The recipient was also reportedly not using the device prior to explant surgery.The recipeint was reportedly explanted due to a mrsa infection.The recipient was not reimplanted.The recipient has healed and remains under the care of infectious disease.No further treatment details will be provided.The external visual inspection revealed the electrode was severed and silicone damage was observed on the top and bottom cover of the device.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode prevented an electrical test from being performed.The device passed the electrical tests performed.The device passed the mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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 3D 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: 24568531
• Report Number: 3006556115-2026-00208
• Device Sequence Number: 8366241
• Product Code: MCM
• UDI-Device Identifier: 00840094455993
• UDI-Public: (01)00840094455993(11)250613(17)280531
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/18/2026

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 Model Number: CI-1601-04
• 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: 03/11/2026
• Supplement Report FDA Received Date: 04/13/2026; 04/29/2026; 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2025
• 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: 46 YR
• Patient Sex: Female