MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS 24 CONTOUR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number	CI24R(CS)
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on july 23,2020.
Event or Problem Description
Per the surgeon, there are plans to explant due to an extrusion of the electrode lead into the external auditory canal (date not reported).There are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report, (b)(6) 2020.
Additional Manufacturer Narrative
It was reported that the device was explanted on (b)(6) 2020, the patient was re-implanted with a new device during the same surgery.This report is submitted on 21 september 2020.
Additional Manufacturer Narrative
The device analysis report is attached.This report is submitted on november 20, 2020.

• Brand Name: NUCLEUS 24 CONTOUR
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10312463
• Report Number: 6000034-2020-01946
• Device Sequence Number: 1071919
• Product Code: MCM
• UDI-Device Identifier: 09321502002349
• UDI-Public: (01)09321502002349
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CI24R(CS)
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/02/2020; 10/30/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 09/20/2020; 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention