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

Model Number CI622

Device Problem Malposition of Device (2616)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on february 08, 2023.

Event Description

Per the clinic, the tip of the electrode array was partially inserted and found to be folded over in the cochlea, resulting in the decision to explant the device.The device was explanted (date not reported).It is unknown if there are plans to re-implant the patient as of the date of this report.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2023.The patient was re-implanted with another cochlear device during the same surgery.This report is submitted on march 14, 2023.

• 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: ken yian chow ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16318690
• MDR Text Key: 309010432
• Report Number: 6000034-2023-00519
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)221104(17)241103
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• 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: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2022
• 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): Required Intervention
• Patient Sex: Male