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

Model Number	CI-1500-04
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993); Intermittent Communication Failure (4038)
Health Effect - Clinical Codes	Head Injury (1879); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
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
The recipient is reportedly experiencing no sound following a head trauma incident.External equipment was exchanged; however, the issue did not resolve.Revision surgery is under consideration.
Additional Manufacturer Narrative
Additional information: section d.4, h.4, d.6b.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
Additional Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode was severed and the bottom cover was dented.The photographic imaging inspection revealed broken and loose components.Additionally, disturbed wires were also observed.System lock could not be obtained at any spacing.The condition of the electrode prevented an electrical test from being performed.The device passed some of the tests performed.The failure of this device is attributed to a damaged hybrid assembly.The device was received with a dented bottom cover, dislodged electrical components, disturbed wires, and cracked hybrid.This is consistent with the no lock reported.This older device configuration is no longer manufactured.

• Brand Name: HIRES¿ 90K ADVANTAGE
• 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: 20482261
• Report Number: 3006556115-2024-01631
• Device Sequence Number: 17186984
• Product Code: MCM
• UDI-Device Identifier: 07630016832185
• UDI-Public: (01)07630016832185(11)160719(17)190531
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/16/2024

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: 05/31/2019
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 12/03/2024; 12/19/2024; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2016
• 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 Age: 73 YR
• Patient Sex: Female