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	Deafness (1801)
Date of Event	08/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on june 21, 2017, by cochlear limited on behalf of (b)(4).Exemption number e2016011.
Event or Problem Description
Per the clinic, the patient experienced a loss of connection to the internal device subsequent to sustaining a head trauma.Troubleshooting and exchange of the external components did not resolve the issue.There are plans to explant the device and to reimplant the patient with a new device; however, it is unknown if this has occurred as of the date of this report.
Additional Manufacturer Narrative
Per the clinic, the patient's device was explanted on (b)(6) 2017.This report is submitted on (b)(6) 2017.

• 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: 6656095
• Report Number: 6000034-2017-01217
• Device Sequence Number: 1478493
• Product Code: MCM
• UDI-Device Identifier: 09321502003216
• UDI-Public: (01)09321502003216(11)140623(17)160623
• 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: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2017

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: 06/23/2016
• Device Model Number: CI 11+11+2M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 08/11/2017; 09/18/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 08/18/2017; 10/11/2017
• 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: 3 YR