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

Model Number CI512

Device Problem Output Problem (3005)

Patient Problem Hearing Impairment (1881)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted september 29, 2020.

Event Description

Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.Reprogramming attempts were made; however, the issue could not be resolved.It is unknown whether there are plans to explant the device as of the date of this report.The patient will continue to be managed by their healthcare provider.

Event Description

It has now been reported that the device was explanted on (b)(6) 2020.The patient was re-implanted with a new device during the same surgery.

Manufacturer Narrative

This report is submitted on october 29, 2020.

• 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, 2109 ; AS 2109
• MDR Report Key: 10597728
• MDR Text Key: 208914167
• Report Number: 6000034-2020-02606
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)160601(17)180531
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 10/29/2020,01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2020
• Distributor Facility Aware Date: 01/07/2020
• Date Report to Manufacturer: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR