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

Model Number	CI-1600-04
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The recipient reportedly experienced tenderness at the implant site a few months ago.The recipient's dermatologist determined there was an infection and referred the recipient to surgeon; however, the recipient did not follow up.The recipient then presented with the internal magnet protruding through skin.The recipient was instructed to immediately stop device use.Explant surgery is scheduled.The recipient will be reimplanted at a later date after the recipient heals.
Additional Manufacturer Narrative
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• 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: 50509667
• Report Number: 3006556115-2026-00986
• Device Sequence Number: 9521596
• Product Code: MCM
• UDI-Device Identifier: 07630016841002
• UDI-Public: (01)07630016841002(11)170512(17)200531
• 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: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2026

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: 05/31/2020
• Device Model Number: CI-1600-04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Supplement Date Received by Manufacturer: 08/31/2026; 09/25/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/23/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2017
• 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