MAUDE Adverse Event Report: Advanced Bionics, LLC HiRes 90K Advantage; Cochlear Implant

Model Number	CI-1500-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Undesired Nerve Stimulation (1980); Wound Infection (2447)
Type of Reportable Event	Serious Injury
Event or Problem Description
The recipient reportedly experienced chronic purulent infections and partial weakness of the facial nerve.The recipient's device was explanted.During the explant surgery, the middle ear was found to be filled with inflammatory granulation tissue, and no symptoms were detected.Examination revealed otosclerosis.The mendelian bone was removed, and the inflammatory granulation tissue of the middle ear was cleaned.The procedure was performed following tympanoplasty.
Additional Manufacturer Narrative
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: corrina desales ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 50437013
• Report Number: 3006556115-2026-01039
• Device Sequence Number: 9167977
• Product Code: MCM
• UDI-Device Identifier: 07630016815805
• UDI-Public: (01)07630016815805(11)170215(17)190131
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 08/20/2026

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 Expiration Date: 01/31/2019
• Device Model Number: CI-1500-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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