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 06/14/2023

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a loss of connection to the internal device.Troubleshooting attempts were made; however, the issue could not be resolved.The implanted device remains.There are plans to explant the device and to re-implant the patient with a new device; however, this has not occurred as of the date of this report.

Event Description

Per the clinic, the device was explanted on (b)(6), 2023, and the patient was re-implanted with a new 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: 17264780
• MDR Text Key: 318440588
• Report Number: 6000034-2023-02120
• 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,Followup
• Report Date: 07/11/2023

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: 12/30/2012
• 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: 07/11/2023
• Distributor Facility Aware Date: 07/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male