MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI622

Device Problems Expulsion (2933); Migration (4003)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 9, 2024.

Event Description

Per the clinic, the patient presented with an infection with discharge post-operatively and the clinical examination revealed a reopening of the external ear canal with the purulent secretion.Antibiotic therapy with iv cefepime was started pre-operatively since (b)(6) 2023.On (b)(6) 2023, the patient was brought into surgery in order to clean the cavity and implant, however, it was noted that the electrode holder was no longer in the cochlea due to basal turn and 2nd turn being completely ossified.The device was explanted and there are no plans to re-implant the patient with a new device.

Manufacturer Narrative

Device analysis report attached.This report is submitted on april 02, 2024.

Manufacturer Narrative

Per the clinic, the patient was hospitalized in (b)(6) 2023 (specific date and duration not reported).It was also reported that the electrode array had extruded into the ear canal.This report is submitted on february 13, 2024.

• Brand Name: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 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: nabila zahari ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18472559
• MDR Text Key: 332372812
• Report Number: 6000034-2024-00158
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)221202(17)241201
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male