MAUDE Adverse Event Report: Advanced Bionics, LLC HiRes¿ 3D Ultra Implant; Cochlear Implant

Model Number	CI-1601-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Balance Problems (4401)
Type of Reportable Event	Serious Injury

• Brand Name: HiRes¿ 3D Ultra Implant
• Common Device Name: Cochlear Implant
• Manufacturer (Section D): Advanced Bionics, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: corrina desales ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 50741597
• Report Number: 3006556115-2026-01044
• Device Sequence Number: 20956186
• Product Code: MCM
• UDI-Device Identifier: 00840094455993
• UDI-Public: (01)00840094455993(11)250611(17)280531
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2025
• 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 Sex: Male