MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT; COCHLEAR IMPLANT

Model Number	CI-1500-04
Medical Device Problem Codes	Mechanical Problem (1384); Impedance Problem (2950)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Event or Problem Description
A review of the recipient's test data indicated impedance issues.The recipient's device was explanted.The recipient was re-implanted with another advanced bionics cochlear device.
Additional Manufacturer Narrative
Additional information: section e.1, e.2, e.3, h.6.Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode was severed and silicone damage was observed on the top and bottom cover of the device.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken wires by the proximal end of the large tubing.System lock was verified.Scanning electron microscopy (sem) analysis revealed cracked insulation on the wires by the proximal end of the large tubing.The device passed the electrical and mechanical tests performed.It is believed that the paralyne wire insulation damage found on the electrode wires are the source of the several open and short circuit reported.A corrective action was implemented.This version of the hires 90k device is no longer distributed.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES 90K¿ ADVANTAGE IMPLANT
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: heidi white ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 23330240
• Report Number: 3006556115-2025-01411
• Device Sequence Number: 15937169
• Product Code: MCM
• UDI-Device Identifier: 07630016832185
• UDI-Public: (01)07630016832185(11)170823(17)200331
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2025

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: 03/31/2020
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2017
• 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 Age: 9 YR
• Patient Sex: Unknown