MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI522

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Failure of Implant (1924)

Event Date 07/31/2023

Event Type  malfunction  

Event Description

Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.Troubleshooting 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 reimplant the patient with another cochlear device as of the date of this report.

• Brand Name: NUCLEUS CI522 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
• MDR Report Key: 17569536
• MDR Text Key: 321400698
• Report Number: 6000034-2023-02627
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502032599
• UDI-Public: (01)09321502032599(11)160719(17)180718
• 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: 08/18/2023,07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/18/2018
• Device Model Number: CI522
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2023
• Distributor Facility Aware Date: 07/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Female