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

Model Number	CI-1600-04
Medical Device Problem Codes	Mechanical Problem (1384); Unstable Impedance (4085)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/28/2026
Type of Reportable Event	Malfunction

• Brand Name: HiRes¿ Ultra 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: 50600846
• Report Number: 3006556115-2026-01010
• Device Sequence Number: 10710097
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)171215(17)201231
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 08/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: CI-1600-04
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2017
• 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
• Patient Sex: Male