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

Model Number	CI-1600-05
Medical Device Problem Codes	Mechanical Problem (1384); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/10/2023
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 reportedly experienced no sound.Device testing revealed results within normal limits.Imaging confirmed device placement.External equipment was exchanged and programming adjustments were made; however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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 silicone damage was observed on the bottom cover of the device.This is believed to have occurred during revision surgery.In addition, this inspection revealed broken electrodes above the ground ring.The photographic imaging inspection revealed broken electrode wires above the ground ring.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 scanning electron microscopy (sem) analysis revealed tensile breaks of electrodes above the ground ring.The device passed the mechanical tests performed.Sem analysis revealed broke electrode wires above the ground ring.It is believed that these breaks caused the open impedances measured at the clinic.Advanced bionics will continue to monitor failure modes of this type.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¿ ULTRA 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: 18051351
• Report Number: 3006556115-2023-01860
• Device Sequence Number: 20852230
• Product Code: MCM
• UDI-Device Identifier: 07630016877988
• UDI-Public: (01)07630016877988(11)220111(17)241231
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2023

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: 12/31/2024
• Device Model Number: CI-1600-05
• 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
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 12/15/2023; 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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: 7 YR
• Patient Sex: Male