MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI622 Cochlear Implant with Slim Straight Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI622
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Hematoma (1884); Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient developed a hematoma which subsequently led to an infection at the implant site after a magnet replacement surgery for mri.It was also reported that the patient experienced loss of electrode function, high impedance and bone growth over the package.The patient was treated with oral antibiotics (specific date and duration not reported) and the device was explanted on (b)(6) 2026.The patient was not reimplanted.

• Brand Name: Nucleus CI622 Cochlear Implant with Slim Straight 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: rosdeelaila zulkifli ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; wilayah persekutuan, kuala lumpur 59200 ; MY 59200
• MDR Report Key: 50864910
• Report Number: 6000034-2026-03438
• Device Sequence Number: 13117964
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/23/2026

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: 05/17/2023
• Device Model Number: CI622
• Device Catalogue Number: P783829
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2021
• 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: Male