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	No Device Output (1435)
Health Effect - Clinical Code	Hearing Impairment (1881)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is submitted on march 07, 2019, by cochlear limited on behalf of (b)(4).Exemption number e2016011.
Event or Problem Description
Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device, however, the issue could not be resolved.The implanted device remains.It is unknown if there are plans to explant the device and reimplant the patient with a new device as of the date of this report.
Additional Manufacturer Narrative
It was reported the device was explanted and the patient was re-implanted with another manufacturer's device.This report is filed on july 04, 2019.

• 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: 8397355
• Report Number: 6000034-2019-00327
• Device Sequence Number: 240424
• Product Code: MCM
• UDI-Device Identifier: 09321502003216
• UDI-Public: (01)09321502003216(11)140925(17)160924
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/24/2016
• Device Model Number: CI 11+11+2M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 07/04/2019
• 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