MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI632

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Failure of Implant (1924)

Event Date 06/06/2023

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.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.Additional information has been requested but has not been made available as of the date of this report.

Event Description

Per the clinic, the device was explanted on (b)(6) 2023, and the patient was reimplanted with another cochlear device during the same surgery.

• Brand Name: NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 17223639
• MDR Text Key: 318069262
• Report Number: 6000034-2023-02038
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502036580
• UDI-Public: (01)09321502036580(11)211102(17)231101
• 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,Followup
• Report Date: 10/11/2023,09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2023
• Device Model Number: CI632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2023
• Distributor Facility Aware Date: 09/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female