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

Model Number	CI 11+11+2M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, patient experienced no benefit with the implant leading to device non-use.The device was explanted on (b)(6) 2020 and there are no plans to reimplant the patient with a new device as of the date of this report.

• Brand Name: NUCLEUS 24 DOUBLE ARRAY
• 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: 12876679
• Report Number: 6000034-2021-03612
• Device Sequence Number: 4528824
• Product Code: MCM
• UDI-Device Identifier: 09321502003216
• UDI-Public: (01)09321502003216(11)150709(17)170708
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2021
• Report Date (Section F): 11/26/2021

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 Expiration Date: 07/08/2017
• Device Model Number: CI 11+11+2M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2021
• 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
• Patient Age: 5 YR
• Patient Sex: Male
• Date Report Sent to FDA: 11/26/2021