MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number	CI24RE (CA)
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Facial Paralysis (4585); Infectious Otitis Media (4815); Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a sudden facial paralysis which begins after the patient went to the dentist (specific date not reported).The patient was then treated with corticosteroid (specific date and duration not reported).The patient also experienced a middle ear infection (suppuration) and biofilm formation at the implant site which was treated with oral antibiotics (specific date and duration not reported).The patient also experienced a gradual increase in hearing performance and eventually on (b)(6) 2018 (specific date not reported), the patient suddenly stopped responding to sound.Neural response telemetry (nrt) was attempted; however, no measurements were obtained.Hardware exchange, troubleshooting and reprogramming attempts were made; however, the issue could not be resolved.The patient underwent an exploration revision surgery on (b)(6) 2019, which revealed granulation tissue around facial nerve, infection at the middle ear and biofilm formation at the implant site.Subsequently, the device was explanted (specific date not reported), and the patient was reimplanted with another cochlear device (specific date not reported).

• Brand Name: NUCLEUS FREEDOM IMPLANT WITH CONTOUR ADVANCE ELECTRODE
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: asyikin zulkhairi ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 25173318
• Report Number: 6000034-2026-01901
• Device Sequence Number: 18676604
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)120825(17)140824
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: 08/24/2014
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2012
• 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 Sex: Female