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

Model Number	CI-1400-02H
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
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
The recipient reportedly experienced decreased performance.A review of the recipient¿s test data indicated impedance issues.The recipient's device was explanted on (b)(6) 2022.The recipient was reimplanted with another advanced bionics cochlear device on (b)(6) 2022.
Additional Manufacturer Narrative
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 sliced silicone overmold on the bottom cover, the fantail and on the electrode lead.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires in the fantail region.System lock was verified.The condition of the electrode prevented an electrical test from being performed.The device passed the electrical tests performed.Scanning electron microscopy (sem) analysis revealed evidence of fatigue breaks between the fantail and the electrode ground ring.The device passed the mechanical tests performed.Photographic imaging inspection revealed broken wires in the fantail region.It is believed that these breaks caused the performance decrease.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¿ IMPLANT
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: laurel masamitsu ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 16309500
• Report Number: 3006556115-2023-00154
• Device Sequence Number: 6132201
• Product Code: MCM
• UDI-Device Identifier: 07630016816260
• UDI-Public: (01)07630016816260(11)150820(17)170731
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P960058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• 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): 01/24/2023

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: 07/31/2017
• Device Model Number: CI-1400-02H
• 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: 02/06/2023
• Supplement Report FDA Received Date: 07/11/2023; 10/02/2023; 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2015
• 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: Male