MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 22; NUCLEUS 22 COCHLEAR IMPLANT SYSTEM

Model Number CI22M

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

This report is submitted on march 19, 2024.

Event Description

Per the clinic, the patient experienced shocking sensation, pain with stimulation, a sudden change in sound quality and loudness discomfort.Reprogramming attempts were made; however, the issue could not be resolved.The implanted device remains.

• Brand Name: NUCLEUS 22
• Type of Device: NUCLEUS 22 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: yaneesa vetsandonphong ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18927540
• MDR Text Key: 337952451
• Report Number: 6000034-2024-00945
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840024
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CI22M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 37 YR
• Patient Sex: Female