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

Model Number	CI-1601-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Discomfort (2330)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The recipient's site was no longer bleeding and was activated.The recipient is wearing the device.This is the report.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 taken to the emergency room a few days after implant due to bleeding at the incision site.The recipient presented with pain/discomfort.The incision was reportedly reglued.An ultrasound was performed and revealed a small pocket of fluid.The recipient's pain was reportedly manageable.

• 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: lacey o'linn ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 24305060
• Report Number: 3006556115-2026-00079
• Device Sequence Number: 9679631
• Product Code: MCM
• UDI-Device Identifier: 00840094455993
• UDI-Public: (01)00840094455993(11)250902(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2025
• 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; Hospitalization
• Patient Age: 6 YR
• Patient Sex: Male