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

Model Number	CI-1500-04
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The recipient reportedly experienced non auditory sensations.External equipment was exchanged and programming adjustments were made, however the issue did not resolve.Some device testing could not be completed due to recipient discomfort.Device testing completed revealed abnormal results.Revision surgery will be scheduled.
Additional Manufacturer Narrative
Additional information: section d.9.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 silicone damage was observed on the top and bottom cover of the device.These are believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The failure of this device is attributed to a short at the analog integrated circuit.It is believed that electrostatic discharge (esd) led to an overload voltage, damaging structures inside the integrated circuit.This ultimately caused the device to cease functioning.A corrective action was implemented.This older device configuration is not currently manufactured.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¿ IMPLANT
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: jennifer rhudy ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 19164794
• Report Number: 3006556115-2024-00622
• Device Sequence Number: 15312389
• Product Code: MCM
• UDI-Device Identifier: 07630016832185
• UDI-Public: (01)07630016832185(11)160819(17)190531
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/02/2024

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: 05/31/2019
• Device Model Number: CI-1500-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/23/2024
• Supplement Report FDA Received Date: 05/21/2024; 06/18/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2016
• 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
• Patient Age: 63 YR
• Patient Sex: Female