MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 22; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI22M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hearing Impairment (1881)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced poor performance with the device.Reprogramming attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2022.The patient was re-implanted with a new device in the same procedure.

Manufacturer Narrative

This report is submitted on june 17, 2022.

Manufacturer Narrative

The device analysis report is attached.This report is submitted on july 11, 2022.

• Brand Name: NUCLEUS 22
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: roberta loveday ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 14724633
• MDR Text Key: 294262468
• Report Number: 6000034-2022-01783
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P890027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI22M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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