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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hearing Impairment (1881); Undesired Nerve Stimulation (1980); Pain (1994)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on 18 march 2020.
Event or Problem Description
Per the clinic, the patient experienced pain, non-auditory sensations, performance decrement and extrusion of the electrode array into the external auditory canal.Subsequently the device was explanted on (b)(6) 2019.There are no plans to re-implant the patient with a new device as of the date of this report.
Additional Manufacturer Narrative
This report is submitted on 22 april 2020.

• 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: 9845641
• Report Number: 6000034-2020-00748
• Device Sequence Number: 14174731
• Product Code: MCM
• UDI-Device Identifier: 09321502003216
• UDI-Public: (01)09321502003216(11)100208(17)120207
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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 Expiration Date: 02/07/2012
• Device Model Number: CI 11+11+2M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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
• Patient Age: 67 YR