MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI522

Device Problem Positioning Failure (1158)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 06, 2024.

Event Description

Per the clinic, the patient experienced pain and poor performance with the device.Reprogramming attempts were made; however, the issue could not be resolved.The tip of the electrode array also was found to be folded over in the cochlea, resulting in the decision to explant the device.The device was explanted on (b)(6) 2023, and patient was reimplanted with another device during the same surgery.

Manufacturer Narrative

Device analysis report attached.This report is submitted on april 12, 2024.

• Brand Name: NUCLEUS CI522 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: amirah rosly ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18843390
• MDR Text Key: 336955857
• Report Number: 6000034-2024-00726
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)160408(17)180407
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/07/2018
• Device Model Number: CI522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• 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): Required Intervention
• Patient Sex: Male