MAUDE Adverse Event Report: Cochlear Ltd Cochlear¿ Nucleus® Nexa® cochlear implant with Contour Advance® electrode; Cochlear¿ Nucleus® Nexa® System

Model Number	CI1012
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Calibration Problem (2890); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Pain (1994); Vertigo (2134); Facial Paralysis (4585)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced sounds too soft, pain/non-auditory sensations, poor performance with the device, vertigo and a half sided facial paralysis on the side of the implant.The impedances has also increased and some channels were out of compliance which leads to device nonuse.The patient was subsequently hospitalized for administration of iv cortisone and antibiotics.The facial paralysis was resolved after two days and the impedance level normalized.The patient was discharged on (b)(6), 2025.However, the impedances increased again two days later, and eleven electrodes were out of compliance one week later.Reprogramming attempts were made, however the issue did not resolved.The patient was hospitalized again on (b)(6), 2025.The external sound processor remained switched off and the next day, the impedances dropped significantly.The patient was administered with another round of steroid treatment during the second hospitalization on (b)(6), 2025.The high impedance was normalized again after two days.Reprogramming were attempted again, however the issue did not resolved.Subsequently, the device was explanted on (b)(6), 2026.

• Brand Name: Cochlear¿ Nucleus® Nexa® cochlear implant with Contour Advance® electrode
• Common Device Name: Cochlear¿ Nucleus® Nexa® 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: nur fitrahana mohd yusop ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50465996
• Report Number: 6000034-2026-03010
• Device Sequence Number: 13214347
• Product Code: MCM
• UDI-Device Identifier: 09321502069847
• UDI-Public: (01)09321502069847(11)241008(17)261007
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P970051/S225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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 Model Number: CI1012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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