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

Model Number CI512

Device Problems Unexpected Therapeutic Results (1631); Expulsion (2933)

Patient Problems Head Injury (1879); Failure of Implant (1924); Tissue Breakdown (2681)

Event Type  malfunction  

Event Description

Per the clinic, the patient sustained a head trauma on (b)(6) 2022 (specific date not reported), exposing the receiver/stimulator.The patient also experienced intermittencies and subsequent loss of connection to the internal device.Hardware exchange, 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 reimplant the patient with another cochlear 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.

• Brand Name: NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE 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: 17084896
• MDR Text Key: 316743334
• Report Number: 6000034-2023-01937
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)170405(17)190404
• 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: 06/08/2023,05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/04/2019
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2023
• Distributor Facility Aware Date: 05/18/2023
• Date Report to Manufacturer: 05/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female