MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CI512

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Failure of Implant (1924)

Event Date 07/25/2023

Event Type  Injury  

Event Description

Per the clinic, the patient experienced intermittencies with the internal device.Hardware exchange, troubleshooting and reprogramming attempts were made; however, the issue could not be resolved.The implanted device remains.There are plans to explant the device and to reimplant the patient with a new device; however, this has not occurred 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 CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE 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: 17358876
• MDR Text Key: 319380044
• Report Number: 6000034-2023-02332
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)100420(17)120419
• 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: 08/18/2023,08/01/2023

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: 04/19/2012
• Device Model Number: CI512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2023
• Distributor Facility Aware Date: 08/01/2023
• Date Report to Manufacturer: 08/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female