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

Model Number CI512

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hearing Loss (1882); Failure of Implant (1924)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 1, 2020.

Event Description

Per the clinic, the patient experienced no sound when using the device.Reprogramming attempts were made; however, the issue could not be resolved.

Manufacturer Narrative

Per the clinic, the device was explanted on (b)(6) 2020 and the patient was reimplanted with a new device during the same surgery.This report is submitted on (b)(6) 2020.

Manufacturer Narrative

The date of awareness was april 7, 2020.This report is submitted on may 1, 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: 10016370
• MDR Text Key: 189586537
• Report Number: 6000034-2020-01152
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)110307(17)130306
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2020,05/22/2020

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 Model Number: CI512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/28/2020
• Date Report to Manufacturer: 05/22/2020
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 04/30/2020
• Supplement Dates Manufacturer Received: 05/04/2020; 05/04/2020
• Supplement Dates FDA Received: 05/03/2020; 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR