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

Model Number CI622

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2024

Event Type  Injury  

Event Description

Per the clinic, the patient underwent a skin flap reduction surgery under general anesthesia on (b)(6) 2024, due to poor magnet retention.The implanted device remains.

Manufacturer Narrative

This report is submitted on march 05, 2024.

• Brand Name: NUCLEUS CI622 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
• Type of Device: 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,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18834273
• MDR Text Key: 336848326
• Report Number: 6000034-2024-00888
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036573
• UDI-Public: (01)09321502036573(11)221201(17)241130
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• 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?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2022
• 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 Age: 55 YR
• Patient Sex: Male