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

Model Number CI22M

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Failure of Implant (1924)

Event Date 01/16/2024

Event Type  malfunction  

Event Description

Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.Troubleshooting and reprogramming attempts were made; however, the issue could not be resolved.The implanted device remains.It is unknown if there are plans to explant the device and to reimplant the patient with a new device as of the date of this report.

• 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
• MDR Report Key: 18673676
• MDR Text Key: 334946494
• Report Number: 6000034-2024-00440
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2024,01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2024
• Distributor Facility Aware Date: 01/16/2024
• Date Report to Manufacturer: 01/16/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Male